Datasets:
recall_number string | recall_type string | firm_name string | product_description string | reason_for_recall string | status string | recall_class null | initiation_date date32 | report_date date32 | distribution_pattern string | product_quantity string | product_ndc string | fei_number string | facility_total_inspections float64 | facility_oai_count float64 | facility_last_classification string | facility_last_inspection date32 | facility_compliance_actions int64 | facility_warning_letters int64 | last_compliance_action_date date32 | preceded_by_oai bool | days_since_last_inspection float64 | failure_category string | failure_subcategory string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D-0109-2018 | drug | Sun Pharmaceutical Industries, Inc. | Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512 | Microbial Contamination of Non-Sterile Products | Terminated | null | 2017-04-18 | 2017-12-20 | Nationwide | N/A | 10631-206 | 3002807972 | 3 | 1 | Official Action Indicated (OAI) | 2012-12-14 | 0 | 0 | null | true | 0 | contamination | microbial contamination |
Z-1794-2014 | device | Boston Scientific Corporation | IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. | Terminated | null | 2014-05-15 | 2014-06-25 | null | 968 units - all models | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | -1 | device_malfunction | manufacturing specification |
D-0761-2017 | drug | Key Pharmacy and Compounding Center | CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Terminated | null | 2017-04-18 | 2017-05-24 | Distributed nationwide in U.S.A., Australia and Canada. | 2 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0392-2022 | device | Wright Medical Technology Inc | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. | The incorrect product is contained in the packaging. | Ongoing | null | 2021-12-03 | 2021-12-29 | null | 23 units | null | 3011007241 | 2 | 0 | No Action Indicated (NAI) | 2019-01-31 | 0 | 0 | null | false | 0 | packaging | wrong product packaged |
D-0942-2017 | drug | Lantheus MI Radipharmaceuticals Inc. | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01 | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent | Terminated | null | 2017-05-18 | 2017-07-12 | Puerto Rico | 26 doses | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | residual solvent |
Z-1141-2023 | device | Baxter Healthcare Corporation | Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. | Ongoing | null | 2023-01-25 | 2023-03-08 | null | 8 units | null | 2618677 | 13 | 5 | Voluntary Action Indicated (VAI) | 2024-07-19 | 2 | 2 | 2013-05-31 | false | -1 | device_malfunction | desaturation risk |
D-1237-2015 | drug | Kremers Urban Pharmaceuticals, Inc. | Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01 | Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. | Terminated | null | 2015-07-07 | 2015-07-22 | Nationwide and Puerto Rico | 16,504 Boxes | null | null | null | null | null | null | 0 | 0 | null | false | null | stability | unknown impurity degradation |
Z-0492-2026 | device | Siemens Healthcare Diagnostics, Inc. | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6; | The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. | Ongoing | null | 2025-10-06 | 2025-11-19 | null | 2802 units (OUS only) | null | 1219913 | 8 | 1 | Voluntary Action Indicated (VAI) | 2022-03-08 | 1 | 1 | 2012-05-10 | false | 0 | device_malfunction | barcode scanning error |
Z-0959-2021 | device | Prytime Medical Devices, Inc. | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1 | There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury. | Terminated | null | 2020-12-14 | 2021-02-17 | null | N/A | null | 3012279212 | 1 | 0 | No Action Indicated (NAI) | 2018-07-17 | 0 | 0 | null | false | 0 | device_malfunction | incorrect needle gauge |
Z-1069-2018 | device | Diagnostica Stago, Inc. | STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT). | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Terminated | null | 2017-10-25 | 2018-03-21 | null | null | 2245451 | 3 | 0 | No Action Indicated (NAI) | 2025-09-09 | 0 | 0 | null | false | -1 | potency | reagent homogeneity defect | |
Z-2795-2020 | device | Bioseal Corporation | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask. | The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient. | Terminated | null | 2019-08-15 | 2020-08-19 | null | 900 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | stress crack leakage |
D-0137-2019 | drug | Pharm D Solutions, LLC | Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20 | Lack of Assurance of Sterility | Terminated | null | 2018-09-10 | 2018-11-07 | Nationwide | 7150 milliliters | null | 3011043554 | 2 | 2 | Official Action Indicated (OAI) | 2018-08-28 | 2 | 1 | 2019-05-22 | true | 0 | sterility | sterility assurance |
Z-2716-2024 | device | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 | A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. | Ongoing | null | 2024-08-08 | 2024-08-28 | null | 6 units | null | 3002807880 | 3 | 1 | Official Action Indicated (OAI) | 2023-01-26 | 0 | 0 | null | true | 0 | device_malfunction | incorrect bolt component |
Z-2620-2023 | device | Copan Diagnostics Inc | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. | Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance | Ongoing | null | 2023-07-14 | 2023-09-27 | null | 2,592 units | null | 1000521444 | 1 | 0 | No Action Indicated (NAI) | 2014-12-10 | 0 | 0 | null | false | 0 | device_malfunction | aspiration defect |
D-1325-2015 | drug | Dr. Reddy's Laboratories, Inc. | Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60 | Failed Dissolution Specifications | Terminated | null | 2015-08-03 | 2015-08-19 | Nationwide | 2,952 bottles | 55111-352 | 3011009040 | 1 | 0 | No Action Indicated (NAI) | 2025-08-21 | 0 | 0 | null | false | -1 | potency | failed dissolution |
D-0869-2016 | drug | Pacifico National, Inc. dba AmEx Pharmacy | Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901. | Non-Sterility: Product tested positive for bacterial contamination. | Terminated | null | 2015-01-20 | 2016-06-01 | Nationwide | 45 syringes | null | 3012034698 | 2 | 0 | Voluntary Action Indicated (VAI) | 2019-05-31 | 0 | 0 | null | false | -1 | sterility | bacterial contamination |
D-0157-2019 | drug | Pharm D Solutions, LLC | HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | Lack of Assurance of Sterility | Terminated | null | 2018-09-10 | 2018-11-07 | Nationwide | 3 vials | null | 3011043554 | 2 | 2 | Official Action Indicated (OAI) | 2018-08-28 | 2 | 1 | 2019-05-22 | true | 0 | sterility | lack of sterility assurance |
D-0417-2016 | drug | Western Drug | Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Terminated | null | 2015-10-19 | 2015-12-09 | Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah | 3 containers | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | sterility assurance |
D-0299-2018 | drug | Medline Industries Inc | Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Terminated | null | 2017-09-21 | 2018-02-07 | Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey | 5,400 cases | null | 3019239304 | 1 | 0 | No Action Indicated (NAI) | 2024-11-04 | 0 | 0 | null | false | -1 | potency | subpotent iodine |
Z-0468-2015 | device | Summit Industries Inc. | The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on. | The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. | Terminated | null | 2014-10-28 | 2014-12-03 | null | 32 | null | 1450503 | 6 | 0 | No Action Indicated (NAI) | 2025-03-20 | 0 | 0 | null | false | -1 | device_malfunction | insufficient weld integrity |
D-0073-2016 | drug | JD & SN Inc., dba Moses Lake Professional Pharmacy | CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | Terminated | null | 2015-07-24 | 2015-11-04 | Nationwide | 30 syringes | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-3149-2024 | device | Boston Scientific Corporation | Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract. | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. | Ongoing | null | 2024-07-18 | 2024-09-25 | null | 10 units | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | 0 | sterility | compromised barrier integrity |
D-0303-2023 | drug | Sentara Infusion Services | MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Terminated | null | 2022-12-27 | 2023-02-22 | Dispensed to Patients Nationwide. | 91 bags | null | 3011627411 | 3 | 2 | Official Action Indicated (OAI) | 2022-12-16 | 1 | 1 | 2016-08-08 | true | 0 | sterility | inadequate assurance |
Z-2264-2014 | device | Hyperion Medical | All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013. | Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece. | Terminated | null | 2013-11-20 | 2014-08-27 | null | 3,346 brochures. Quantity not applicable to web site. | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | uncleared features |
Z-1840-2017 | device | Smith & Nephew, Inc. | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming | Terminated | null | 2017-03-15 | 2017-04-26 | null | N/A | null | 1020279 | 6 | 0 | Voluntary Action Indicated (VAI) | 2021-12-09 | 0 | 0 | null | false | -1 | device_malfunction | blade detachment and fracture |
Z-2051-2019 | device | Cardinal Health 200, LLC | Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363 | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product | Completed | null | 2019-04-30 | 2019-07-31 | null | N/A | null | 3030940002 | 1 | 0 | No Action Indicated (NAI) | 2025-10-30 | 0 | 0 | null | false | -1 | sterility | cartridge barrier defect |
Z-0228-2025 | device | Baxter Healthcare Corporation | a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296. b. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063. | The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system. | Ongoing | null | 2024-09-18 | 2024-11-06 | null | 2,967 beds | null | 2649614 | 7 | 1 | Voluntary Action Indicated (VAI) | 2023-11-29 | 1 | 1 | 2014-07-17 | false | 0 | device_malfunction | nurse call interface failure |
Z-1409-2020 | device | Baxter Healthcare Corporation | Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L | There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. | Terminated | null | 2019-11-15 | 2020-03-11 | null | 101976 devices | null | 2650090 | 9 | 1 | Voluntary Action Indicated (VAI) | 2025-03-26 | 1 | 1 | 2011-01-20 | false | -1 | foreign_material | particulate in caps |
Z-1682-2020 | device | CHANGE HEALTHCARE CANADA COMPANY | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format | Ongoing | null | 2020-02-10 | 2020-04-15 | null | 51 units | null | 3003757840 | 1 | 0 | No Action Indicated (NAI) | 2017-03-02 | 0 | 0 | null | false | 0 | software | heart rate calculation error |
D-0302-2018 | drug | Medline Industries Inc | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Terminated | null | 2017-09-21 | 2018-02-07 | Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey | 2,369 cases | null | 1022110 | 5 | 0 | Voluntary Action Indicated (VAI) | 2015-03-11 | 0 | 0 | null | false | 0 | potency | subpotent iodine |
D-0525-2021 | drug | Cardinal Health Inc. | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 122 inhalers | null | 2000029340 | 2 | 0 | No Action Indicated (NAI) | 2021-11-03 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-2121-2014 | device | Mckesson Medical Immaging | Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. | Terminated | null | 2014-05-05 | 2014-08-06 | null | 659 units | null | null | null | null | null | null | 0 | 0 | null | false | null | software | image indexing discrepancy |
D-0031-2016 | drug | Ohm Laboratories, Inc. | Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Terminated | null | 2015-07-28 | 2015-10-21 | Nationwide. | 29,360 boxes | null | 3003669934 | 2 | 0 | No Action Indicated (NAI) | 2012-08-14 | 0 | 0 | null | false | 0 | potency | superpotent assay OOS |
Z-0664-2021 | device | Boston Scientific Corporation | IceSphere" 1.5 CX 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Completed | null | 2020-11-18 | 2020-12-30 | null | 6,363 units | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | 0 | device_malfunction | needle shaft leaks |
Z-0175-2024 | device | American Contract Systems, Inc. | CVS PCSU SJH, REF SJCV48J | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals. | Ongoing | null | 2023-09-01 | 2023-11-01 | null | 36 cases | null | 3016444870 | 1 | 0 | No Action Indicated (NAI) | 2021-12-07 | 0 | 0 | null | false | 0 | cGMP | improper sterilization process |
Z-1677-2018 | device | Siemens Healthcare Diagnostics, Inc. | IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3) | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin. | Terminated | null | 2018-01-02 | 2018-05-16 | null | N/A | null | 1000660462 | 1 | 0 | No Action Indicated (NAI) | 2013-04-03 | 0 | 0 | null | false | 0 | mislabeling | incomplete instructions |
Z-0550-2020 | device | Boston Scientific Corporation | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | Terminated | null | 2019-10-21 | 2019-12-04 | null | 542 units | null | 2648729 | 5 | 0 | No Action Indicated (NAI) | 2021-07-21 | 0 | 0 | null | false | -1 | mislabeling | incorrect shelf life |
Z-0662-2013 | device | Maquet Cardiovascular, LLC | CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. | In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling. | Terminated | null | 2012-03-27 | 2013-01-16 | null | 29 units (total) | null | 2242352 | 8 | 6 | Official Action Indicated (OAI) | 2024-07-11 | 1 | 1 | 2010-08-11 | false | -1 | device_malfunction | coiled cord failure |
Z-0849-2024 | device | Cardinal Health 200, LLC | Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps. | Ongoing | null | 2023-12-28 | 2024-02-14 | null | 223056 units | null | 3004259653 | 2 | 0 | No Action Indicated (NAI) | 2018-01-18 | 0 | 0 | null | false | 0 | device_malfunction | pump compatibility issue |
Z-0792-2021 | device | Steris Corporation | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713 | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch | Terminated | null | 2020-12-02 | 2021-01-13 | null | 31 cases | null | 1923569 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-03-31 | 0 | 0 | null | false | -1 | packaging | ink migration |
D-1069-2015 | drug | Fallon Wellness Pharmacy, L.L.C. | Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Terminated | null | 2015-03-17 | 2015-05-20 | New York | 15 vials | null | 3007942369 | 3 | 2 | Voluntary Action Indicated (VAI) | 2016-12-06 | 1 | 1 | 2016-02-01 | false | -1 | sterility | sterility assurance failure |
Z-0009-2024 | device | Boston Scientific Corporation | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | Ongoing | null | 2023-07-27 | 2023-10-11 | null | 4990 units | null | 3002095335 | 11 | 0 | No Action Indicated (NAI) | 2025-03-18 | 0 | 0 | null | false | -1 | device_malfunction | incorrect tip curve |
Z-1667-2024 | device | Boston Scientific Corporation | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. | Ongoing | null | 2024-03-21 | 2024-05-22 | null | 847 catheters | null | 3002095335 | 11 | 0 | No Action Indicated (NAI) | 2025-03-18 | 0 | 0 | null | false | -1 | device_malfunction | polyurethane delamination |
Z-0380-2014 | device | Synthes USA HQ, Inc. | 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. | Terminated | null | 2013-07-31 | 2013-12-04 | null | 98 | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | incorrect screw size |
D-0697-2016 | drug | Abbott's Compounding Pharmacy, Inc. | papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Terminated | null | 2016-01-15 | 2016-02-24 | CA | 10 ml | null | 3005529620 | 1 | 1 | Official Action Indicated (OAI) | 2016-01-08 | 1 | 1 | 2017-04-04 | true | 0 | sterility | lack of sterility assurance |
D-0837-2016 | drug | Bryant Ranch Prepack Inc. | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch. | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation. | Terminated | null | 2016-03-25 | 2016-05-11 | Nationwide | 21 bottles (910 extended release tablets) | 63629-3324 | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | formulation type error |
D-0840-2018 | drug | Apotex Inc. | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4 | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Terminated | null | 2018-05-08 | 2018-05-23 | Nationwide in the USA. | 13453 vials | null | 3002906944 | 10 | 2 | No Action Indicated (NAI) | 2025-07-31 | 1 | 1 | 2010-03-29 | false | -1 | potency | subpotent from impurities |
Z-2133-2017 | device | Cardinal Health 200, LLC | Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | Terminated | null | 2017-04-21 | 2017-05-31 | null | null | 3004295444 | 3 | 0 | No Action Indicated (NAI) | 2024-10-30 | 0 | 0 | null | false | -1 | sterility | compromised package seal | |
Z-0758-2022 | device | Boston Scientific Corporation | DREAMTOME 49-30MM/450CM Material Number: M00584030 | Sterility of device is compromised due to a sterile barrier breach | Ongoing | null | 2021-12-22 | 2022-03-23 | null | 32 units | null | 3032507796 | 2 | 0 | No Action Indicated (NAI) | 2016-12-14 | 0 | 0 | null | false | 0 | sterility | barrier breach |
D-760-2015 | drug | Attix Pharmaceuticals | Levosulpiride active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Terminated | null | 2014-11-14 | 2015-04-29 | Nationwide to compounding pharmacies and research organizations. | 14350 grams | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | penicillin cross-contamination |
D-0604-2021 | drug | Fresenius Medical Care Holdings, Inc. | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Terminated | null | 2021-04-28 | 2021-06-16 | Nationwide within the United States | 25 cases | null | 3001451489 | 8 | 4 | Official Action Indicated (OAI) | 2024-10-16 | 3 | 3 | 2023-12-04 | false | -1 | stability | temperature excursion |
Z-1738-2013 | device | St. Jude Medical | Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. | St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica | Terminated | null | 2012-07-26 | 2013-07-24 | null | 70,638 (combined total for Eon and Eon mini systems) | null | 3004936110 | 7 | 3 | No Action Indicated (NAI) | 2024-08-13 | 2 | 2 | 2015-09-30 | false | -1 | device_malfunction | excessive heating burns |
Z-1993-2018 | device | Arrow International Inc | Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1 | Product sterility may be compromised due to unsealed packaging. | Terminated | null | 2018-04-11 | 2018-06-06 | null | 416,055 total products | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | unsealed packaging |
Z-1186-2026 | device | Medline Industries, LP | Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713 | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. | Ongoing | null | 2025-12-12 | 2026-02-04 | null | 0 | null | 3015274459 | 1 | 0 | No Action Indicated (NAI) | 2026-01-05 | 0 | 0 | null | false | -1 | device_malfunction | tubing cracking |
Z-0458-2022 | device | Uromedica Inc. | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. | Terminated | null | 2021-11-22 | 2022-01-12 | null | 18 devices | null | 3003477176 | 4 | 0 | No Action Indicated (NAI) | 2017-01-11 | 0 | 0 | null | false | 0 | device_malfunction | sheath compatibility damage |
Z-2874-2016 | device | Hospira Inc. | LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications. | Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops. | Terminated | null | 2013-03-08 | 2016-09-28 | null | 69 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | motor step mismatch |
Z-0065-2014 | device | Varian Medical Systems, Inc. | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA | The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. | Terminated | null | 2013-08-09 | 2013-10-30 | null | 3 sets | null | 3000206172 | 4 | 0 | No Action Indicated (NAI) | 2022-09-07 | 0 | 0 | null | false | -1 | device_malfunction | template deformation |
Z-2295-2023 | device | MEDLINE INDUSTRIES, LP - Northfield | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A; | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | Ongoing | null | 2023-05-15 | 2023-08-09 | null | 29,126 kits | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | gel sterility failure |
Z-1653-2021 | device | Bard Access Systems Inc. | REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed. | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock | Terminated | null | 2021-04-07 | 2021-05-26 | null | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | connector defect |
Z-1711-2018 | device | Datascope Corporation | BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | Terminated | null | 2017-10-19 | 2018-05-16 | null | 4 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | seal separation defect |
Z-2344-2020 | device | RAYSEARCH LABORATORIES AB | RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. | Terminated | null | 2020-05-18 | 2020-06-17 | null | N/A | null | 3007774465 | 1 | 1 | Official Action Indicated (OAI) | 2022-11-17 | 0 | 0 | null | false | -1 | software | dose calculation error |
Z-2043-2018 | device | Medical Action Industries Inc | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol. | Product sterility potentially compromised. | Terminated | null | 2017-12-11 | 2018-06-06 | null | 31,440 Towels | null | 3007350169 | 1 | 0 | No Action Indicated (NAI) | 2013-05-13 | 0 | 0 | null | false | 0 | sterility | compromised sterility |
D-0327-2015 | drug | Jaymac Pharmaceuticals L.L.C. | J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30. | Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40. | Terminated | null | 2014-12-16 | 2015-01-07 | U.S. including: LA, AR, TX, MS | 5572 Bottles | null | 3002921361 | 2 | 0 | No Action Indicated (NAI) | 2024-01-22 | 1 | 1 | 2010-02-08 | false | -1 | mislabeling | false dye free claim |
Z-0300-2025 | device | Boston Scientific Corporation | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060 | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. | Ongoing | null | 2024-10-10 | 2024-11-20 | null | 960 units | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | 0 | device_malfunction | esophageal fistula risk |
Z-1436-2018 | device | Philips Electronics North America Corporation | Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. | Potential risk for helium gas inside the MR examination room during a magnet quench | Terminated | null | 2018-03-16 | 2018-04-25 | null | 8,205 units in total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | helium gas leak risk |
D-1451-2014 | drug | Shamrock Medical Solutions Group LLC | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg | Terminated | null | 2011-09-27 | 2014-07-30 | Product was shipped to the following states: CO, MA, OH, TX & WY. | 99/240 mg softgel caps | null | 3006706499 | 2 | 2 | Official Action Indicated (OAI) | 2011-02-04 | 1 | 1 | 2010-04-08 | true | 0 | mislabeling | incorrect active ingredient |
Z-0978-2013 | device | Cardinal Health | Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Terminated | null | 2012-12-18 | 2013-04-03 | null | Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736 | null | 3007123846 | 4 | 0 | No Action Indicated (NAI) | 2022-06-24 | 0 | 0 | null | false | -1 | packaging | compromised sterility barrier |
Z-0638-2019 | device | Cardinal Health 200, LLC | Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error. | Terminated | null | 2018-10-31 | 2018-12-26 | null | 1,475,095 pairs total | null | 3004335638 | 2 | 0 | No Action Indicated (NAI) | 2022-06-27 | 0 | 0 | null | false | -1 | mislabeling | incorrect breakthrough times |
Z-2576-2019 | device | Medtronic Vascular | SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | Completed | null | 2019-03-15 | 2019-10-09 | null | 18 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | material degradation |
D-1570-2020 | drug | AAA Cosmetica, SA de CV | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | Chemical Contamination: Product contains methanol. | Terminated | null | 2020-07-02 | 2020-09-09 | Distributed Nationwide in the USA | 204,768 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | methanol presence |
D-0668-2023 | drug | Central Admixture Pharmacy Services, Inc. | Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Terminated | null | 2023-04-28 | 2023-05-31 | Nationwide in the USA. | 12,888 bags | null | 3009590582 | 4 | 3 | Official Action Indicated (OAI) | 2023-03-30 | 3 | 3 | 2024-03-29 | true | 0 | sterility | sterility assurance failure |
D-0777-2022 | drug | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Terminated | null | 2022-04-05 | 2022-04-27 | Nationwide within United States | 189 vials | null | 3014229024 | 2 | 1 | Voluntary Action Indicated (VAI) | 2025-09-05 | 1 | 1 | 2022-11-18 | false | -1 | sterility | cGMP deviations |
Z-2077-2020 | device | Becton Dickinson & Company | BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276 | The kits contain surgical gowns which were subject to a recall by the supplier. | Terminated | null | 2020-02-26 | 2020-05-27 | null | 1262 total | null | 1111096 | 5 | 0 | No Action Indicated (NAI) | 2022-06-08 | 0 | 0 | null | false | -1 | other | supplier component recall |
D-0423-2022 | drug | Edge Pharma, LLC | Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01 | Lack of Assurance of Sterility | Terminated | null | 2021-12-06 | 2022-02-02 | nationwide | 1773 syringes | null | 3010490167 | 4 | 4 | Official Action Indicated (OAI) | 2021-11-30 | 2 | 1 | 2022-06-10 | true | 0 | sterility | lack of assurance |
D-0487-2015 | drug | Apotex Inc. | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4. | CGMP Deviations: Product excipient was not re-tested at the appropriate date. | Terminated | null | 2015-02-12 | 2015-04-22 | U.S. Nationwide. | 33,795 Bottles | null | 3000114091 | 6 | 0 | Voluntary Action Indicated (VAI) | 2025-05-09 | 0 | 0 | null | false | -1 | cGMP | excipient retesting |
Z-0016-2017 | device | Panoramic Rental Corp. | Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images. | Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders. | Terminated | null | 2016-08-19 | 2016-10-12 | null | 13,340 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | safety nut failure |
D-1183-2015 | drug | Lincare, Inc. | DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | Unknown | null | 3000215110 | 1 | 0 | Voluntary Action Indicated (VAI) | 2015-08-21 | 0 | 0 | null | false | -1 | sterility | lack of sterility assurance |
Z-0753-2024 | device | Randox Laboratories Ltd. | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples | Ongoing | null | 2023-11-20 | 2024-01-24 | null | 108 kits | null | null | null | null | null | null | 0 | 0 | null | false | null | software | calibration algorithm error |
Z-2423-2020 | device | Tosoh Bioscience Inc | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. | Terminated | null | 2020-05-22 | 2020-07-01 | null | 529 | null | 3005529799 | 6 | 2 | Voluntary Action Indicated (VAI) | 2019-10-11 | 2 | 2 | 2016-08-05 | false | 0 | software | detection algorithm failure |
D-709-2013 | drug | Lowlite Investments, Inc. D/B/A Olympia Pharmacy | Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Ongoing | null | 2013-05-29 | 2013-07-17 | Nationwide and PR | 1 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | QC process deficiency |
Z-0911-2016 | device | Abbott Vascular | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve. | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture. | Terminated | null | 2016-02-04 | 2016-03-16 | null | 7,600 units total (2,300 units in US) | null | 3006169760 | 1 | 0 | No Action Indicated (NAI) | 2011-07-20 | 0 | 0 | null | false | 0 | device_malfunction | mandrel fracture |
Z-2354-2020 | device | Acuity Surgical Devices, LLC | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. | Ongoing | null | 2019-01-07 | 2020-06-17 | null | A total of 27 lots producing 178 units | null | 3010866843 | 4 | 0 | Voluntary Action Indicated (VAI) | 2025-01-27 | 0 | 0 | null | false | -1 | device_malfunction | improper screw seating |
Z-1905-2012 | device | Invacare Corporation | TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position. | Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse. | Terminated | null | 2012-04-06 | 2012-07-11 | null | 665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified. | null | 1000220413 | 7 | 1 | No Action Indicated (NAI) | 2023-03-30 | 0 | 0 | null | false | -1 | device_malfunction | electrical short risk |
Z-1913-2019 | device | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. | A steady upward trend in blank (u) absorbance was observed | Terminated | null | 2019-05-03 | 2019-07-10 | null | 3,386 | null | 2517506 | 4 | 1 | Voluntary Action Indicated (VAI) | 2014-04-23 | 1 | 1 | 2012-06-29 | false | 0 | stability | degradation detection |
Z-2472-2021 | device | Abbott Laboratories | Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc. | Ongoing | null | 2021-07-26 | 2021-09-22 | null | 4,833 systems | null | 1513768 | 24 | 0 | Voluntary Action Indicated (VAI) | 2025-04-24 | 0 | 0 | null | false | -1 | software | reagent status display |
Z-1764-2019 | device | Teleflex Medical | Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube. | Terminated | null | 2019-05-24 | 2019-06-26 | null | 3238600 units | null | 3005428244 | 1 | 0 | No Action Indicated (NAI) | 2010-06-01 | 0 | 0 | null | false | 0 | device_malfunction | connector disconnection |
D-0384-2024 | drug | Optikem International, Inc. | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150 | Lack of Assurance of Sterility | Ongoing | null | 2024-02-29 | 2024-03-20 | Product distributed Nationwide in the USA | 46,621 bottles | null | 1720129 | 5 | 1 | Official Action Indicated (OAI) | 2024-03-01 | 2 | 2 | 2024-08-13 | false | -1 | sterility | sterility assurance failure |
Z-0045-2013 | device | Immunodiagnostics Systems Ltd | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser. | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. | Terminated | null | 2012-08-10 | 2012-10-17 | null | 29 | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | incorrect product classification |
Z-0460-2017 | device | ICU Medical, Inc. | CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Terminated | null | 2016-09-27 | 2016-11-23 | null | 100 units | null | 1713468 | 7 | 0 | No Action Indicated (NAI) | 2024-09-26 | 0 | 0 | null | false | -1 | device_malfunction | potential leak defect |
Z-1555-2020 | device | Boston Scientific Corporation | Imager II 5F Angiographic Catheters, 5 units per package. | Potential for tip detachment of Imager II 5F Angiographic Catheters | Ongoing | null | 2020-02-11 | 2020-04-01 | null | 1068827 Single Units | null | 3032507796 | 2 | 0 | No Action Indicated (NAI) | 2016-12-14 | 0 | 0 | null | false | 0 | device_malfunction | tip detachment |
D-0077-2019 | drug | Product Quest Manufacturing LLC | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Terminated | null | 2018-08-03 | 2018-10-24 | Nationwide in the USA | Unknown | null | 3001554391 | 4 | 0 | Voluntary Action Indicated (VAI) | 2017-01-27 | 0 | 0 | null | false | 0 | cGMP | manufacturing conditions |
Z-1825-2023 | device | Remote Diagnostic Technologies Ltd. | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM". | Ongoing | null | 2023-05-08 | 2023-06-21 | null | 1147 | null | 3003832357 | 3 | 0 | No Action Indicated (NAI) | 2024-05-31 | 0 | 0 | null | false | -1 | device_malfunction | communication failure |
D-1180-2022 | drug | Golden State Medical Supply Inc. | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. | CGMP Deviations | Ongoing | null | 2022-03-16 | 2022-07-13 | Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI | 1,424 bottles | 60429-183 | 3006458969 | 10 | 1 | No Action Indicated (NAI) | 2025-06-11 | 1 | 1 | 2011-04-26 | false | -1 | cGMP | manufacturing deviations |
Z-2105-2020 | device | Cardinal Health Inc. | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | The feeding spike sets may leak at the interface of the tube and spike connector. | Ongoing | null | 2019-12-26 | 2020-06-03 | null | 114,731, 290 total units | null | 3003474118 | 3 | 0 | No Action Indicated (NAI) | 2025-02-19 | 0 | 0 | null | false | -1 | device_malfunction | leaking connector interface |
Z-0695-2022 | device | ev3 Inc. | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. | Terminated | null | 2022-02-04 | 2022-03-16 | null | 245 devices | null | 2183870 | 6 | 0 | No Action Indicated (NAI) | 2022-11-03 | 0 | 0 | null | false | -1 | device_malfunction | tip detachment risk |
Z-1304-2014 | device | Medtronic Vascular, Inc. | FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. | Terminated | null | 2014-03-03 | 2014-04-02 | null | 50 Total all sizes: 18 in US, 32 Internationally. | null | 3001452571 | 10 | 0 | No Action Indicated (NAI) | 2019-07-11 | 0 | 0 | null | false | -1 | device_malfunction | component not removed |
D-0599-2017 | drug | Synergy Rx | CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676 | Lack of Assurance of Sterility: There are also CGMP Deviations. | Terminated | null | 2017-02-10 | 2017-03-22 | Nationwide within the United States | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0211-2016 | device | Boston Scientific Corporation | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System. | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture. | Terminated | null | 2015-10-09 | 2015-11-18 | null | 955 single units (191 5-packs) | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | 0 | device_malfunction | wire fracture |
D-0975-2023 | drug | Central Admixture Pharmacy Services, Inc. | oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Terminated | null | 2023-07-14 | 2023-08-09 | Nationwide in the USA | 751 bags | null | 1000307034 | 2 | 0 | Voluntary Action Indicated (VAI) | 2015-11-20 | 0 | 0 | null | false | 0 | sterility | inadequate validation |
D-0246-2026 | drug | Glenmark Pharmaceuticals Inc., USA | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. | Ongoing | null | 2025-12-30 | 2026-01-07 | Nationwide within the United States | 96,948 packs | 68462-105 | 3005658103 | 3 | 0 | No Action Indicated (NAI) | 2016-12-05 | 3 | 3 | 2010-03-16 | false | 0 | packaging | defective blister seals |
End of preview. Expand
in Data Studio
FDA Recall Intelligence
74,000+ FDA drug and device recalls enriched with facility inspection history, compliance action context, and AI-classified failure categories. Answers the question: what led to this recall, and what's the facility's track record?
Why This Dataset Exists
FDA publishes recall data separately from inspection and enforcement data. To understand why a recall happened and whether the facility has a pattern of problems, analysts must manually cross-reference 3–4 databases. This dataset pre-joins that context into a single row per recall.
Schema
| Column | Type | Description |
|---|---|---|
recall_number |
str | FDA recall identifier |
recall_type |
str | "drug" or "device" |
firm_name |
str | Recalling firm |
product_description |
str | Product being recalled |
reason_for_recall |
str | FDA-stated reason (free text) |
status |
str | Ongoing, Completed, Terminated |
recall_class |
str | Class I / II / III (device recalls) |
initiation_date |
date | When the recall was initiated |
report_date |
date | When FDA was notified |
distribution_pattern |
str | Geographic distribution of recalled product |
product_quantity |
str | Amount of product recalled |
product_ndc |
str | National Drug Code (drug recalls) |
fei_number |
str | Matched FDA Establishment Identifier |
facility_total_inspections |
int | Inspection count for this facility |
facility_oai_count |
int | Serious inspection failures at this facility |
facility_last_classification |
str | Most recent inspection outcome |
facility_last_inspection |
date | When facility was last inspected |
facility_compliance_actions |
int | Warning Letters / Injunctions / Seizures |
facility_warning_letters |
int | Warning Letters issued to this facility |
preceded_by_oai |
bool | Was the most recent inspection before this recall an OAI? |
days_since_last_inspection |
int | Days between last inspection and recall initiation |
Key Insights
- 74,000+ total recalls (23,000+ drug, 50,000+ device)
- 79% matched to an FDA-inspected facility
- 4,100+ recalls preceded by an OAI inspection
- Date range: 2005 – present
AI-Enriched Failure Categories (Drug Recalls)
17,000+ drug recalls have been classified by failure mode using Claude AI:
| Category | Count | Share |
|---|---|---|
| Sterility | 6,469 | 37% |
| cGMP Deviations | 3,536 | 20% |
| Contamination | 1,922 | 11% |
| Potency | 1,573 | 9% |
| Mislabeling | 1,416 | 8% |
| Stability | 890 | 5% |
| Foreign Material | 694 | 4% |
Each classification includes a subcategory (e.g., "penicillin cross-contamination", "subpotent API", "label mixup") for granular analysis. Device recall classifications are in progress.
Sample
This is a 10% random sample. The full dataset is available for purchase — details below.
Sources
- OpenFDA Drug Enforcement (drug recalls)
- OpenFDA Device Enforcement (device recalls)
- DDAPI Inspections & Classifications (facility context)
- DDAPI Compliance Actions (enforcement context)
License
Derived from U.S. government public data. AI classifications generated by Claude (Anthropic). Provided as-is.
Purchase
For the full dataset: https://mandiasdata.gumroad.com/l/fda-recall-intelligence
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