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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Z-2668-2025 | device | Siemens Medical Solutions USA, Inc | MAGNETOM Vida Fit. Model Number: 11410481. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the ... | Ongoing | null | 2025-08-28 | 2025-10-08 | null | 41 units | null | 2240869 | 3 | 0 | Voluntary Action Indicated (VAI) | 2022-10-26 | 0 | 0 | null | false | 0 | device_malfunction | venting system blockage |
Z-0459-2026 | device | Abbott Medical | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Pa... | Ongoing | null | 2025-10-06 | 2025-11-19 | null | 722 units | null | 3009600098 | 3 | 0 | No Action Indicated (NAI) | 2014-01-29 | 0 | 0 | null | false | 0 | device_malfunction | communication loss |
Z-0116-2020 | device | GE Healthcare, LLC | Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-000-004795 ... | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correcti... | Ongoing | null | 2019-07-19 | 2019-12-25 | null | 19351 devices | null | null | null | null | null | null | 0 | 0 | null | false | null | software | cybersecurity vulnerability |
Z-1563-2025 | device | Baxter Healthcare Corporation | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | Ongoing | null | 2025-03-21 | 2025-04-23 | null | 70627 units | null | 1025114 | 11 | 5 | Official Action Indicated (OAI) | 2024-02-09 | 0 | 0 | null | true | 0 | foreign_material | rubber band contamination |
Z-0697-2025 | device | MEDLINE INDUSTRIES, LP - Northfield | HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning. | Ongoing | null | 2024-11-18 | 2024-12-25 | null | 1464 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | adhesive defect |
D-0475-2021 | drug | Cardinal Health Inc. | Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 41 bottles | null | 3003474118 | 3 | 0 | No Action Indicated (NAI) | 2025-02-19 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-3399-2018 | device | B. Braun Medical, Inc. | EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administr... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 3900 | null | 2523676 | 11 | 0 | Voluntary Action Indicated (VAI) | 2025-05-16 | 0 | 0 | null | false | -1 | device_malfunction | connector seal failure |
D-1312-2019 | drug | Inopak Ltd | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bott... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Terminated | null | 2019-04-22 | 2019-06-05 | Nationwide in the USA | 17,850 pounds per batch | null | 1000122232 | 7 | 3 | Official Action Indicated (OAI) | 2023-08-03 | 2 | 2 | 2023-12-15 | false | -1 | cGMP | manufacturing practices violation |
D-0066-2017 | drug | Pharmedium Services, LLC | lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79 | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Terminated | null | 2015-07-17 | 2016-10-19 | Nationwide | 830 syringes | null | 3000717703 | 4 | 3 | Official Action Indicated (OAI) | 2017-12-22 | 1 | 1 | 2014-07-18 | false | -1 | stability | potency loss syringes |
D-1299-2022 | drug | Eco Lips, Inc | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 | Failed Dissolution Specifications | Terminated | null | 2022-06-29 | 2022-08-03 | CA | 35,313 tubes | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | failed dissolution |
Z-0133-2019 | device | Zimmer Biomet, Inc. | Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | Terminated | null | 2018-08-08 | 2018-10-24 | null | 12 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | compromised packaging |
Z-0827-2022 | device | Mevion Medical Systems, Inc. | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. | Ongoing | null | 2022-02-01 | 2022-04-06 | null | 39 (36 US, 3 OUS) | null | 3007087027 | 4 | 0 | Voluntary Action Indicated (VAI) | 2020-03-05 | 0 | 0 | null | false | 0 | device_malfunction | control pendant failure |
D-0379-2022 | drug | Dr. Reddy's Laboratories, Inc. | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India. | Failed Dissolution Specifications | Terminated | null | 2022-01-04 | 2022-01-26 | Nationwide in the USA | 2,352 boxes | null | 3011009040 | 1 | 0 | No Action Indicated (NAI) | 2025-08-21 | 0 | 0 | null | false | -1 | potency | failed dissolution |
D-1148-2017 | drug | Bella Pharmaceuticals, Inc. | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Terminated | null | 2017-08-15 | 2017-09-20 | Nationwide within USA | 10 vials | null | 3013442632 | 1 | 1 | Official Action Indicated (OAI) | 2017-07-18 | 1 | 1 | 2019-02-11 | true | 0 | sterility | sterility assurance failure |
Z-0594-2018 | device | DePuy Orthopaedics, Inc. | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130). | Terminated | null | 2017-07-12 | 2018-02-21 | null | 19 | null | 3005572635 | 1 | 0 | No Action Indicated (NAI) | 2009-01-12 | 0 | 0 | null | false | 0 | mislabeling | incorrect device packaged |
Z-1654-2014 | device | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. | Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | Terminated | null | 2014-04-10 | 2014-06-04 | null | 155,345 kits | null | null | null | null | null | null | 0 | 0 | null | false | null | software | assay interference |
Z-2301-2014 | device | Zimmer, Inc. | Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. | Terminated | null | 2013-06-10 | 2014-08-27 | null | 70,986 distribution events | null | 1000220733 | 10 | 4 | No Action Indicated (NAI) | 2022-07-27 | 0 | 0 | null | false | -1 | device_malfunction | breakage of prosthetic component |
Z-1672-2023 | device | Smith & Nephew, Inc. | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, S... | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision. | Ongoing | null | 2023-05-02 | 2023-06-07 | null | 2146 units | null | 1020279 | 6 | 0 | Voluntary Action Indicated (VAI) | 2021-12-09 | 0 | 0 | null | false | 0 | device_malfunction | higher revision rate |
Z-3350-2018 | device | B. Braun Medical, Inc. | CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of an... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 10500 | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | -1 | device_malfunction | connector failure |
Z-1374-2024 | device | Boston Scientific Corporation | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such ... | Ongoing | null | 2024-02-20 | 2024-04-03 | null | 985 units | null | 3005099803 | 7 | 0 | Voluntary Action Indicated (VAI) | 2024-11-26 | 0 | 0 | null | false | -1 | device_malfunction | ischemia risk |
Z-0716-2024 | device | Olympus Corporation of the Americas | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination. | Ongoing | null | 2023-12-04 | 2024-01-24 | null | 3001 units | null | 1000635022 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-03-10 | 1 | 1 | 2015-08-12 | false | 0 | sterility | non-sterile device |
Z-1452-2022 | device | Stryker Instruments Div. of Stryker Corporation | SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures. | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error. | Terminated | null | 2022-06-15 | 2022-07-27 | null | 44 units | null | null | null | null | null | null | 0 | 0 | null | false | null | software | sponge counting logic |
D-1197-2015 | drug | Lincare, Inc. | Vancomycin 1000mg / NS 100mL, Packaged in 100 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 | 1000307060 | 1 | 0 | Voluntary Action Indicated (VAI) | 2010-09-22 | 0 | 0 | null | false | 0 | sterility | sterility assurance failure |
Z-1689-2025 | device | Boston Scientific Corporation | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to per... | Ongoing | null | 2025-03-24 | 2025-05-07 | null | 67 units | null | 3002095335 | 11 | 0 | No Action Indicated (NAI) | 2025-03-18 | 0 | 0 | null | false | 0 | software | incorrect demo settings |
Z-0376-2022 | device | Cardinal Health | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Potential for open packaging seals compromising the sterility of the surgical gowns | Ongoing | null | 2021-11-02 | 2021-12-22 | null | 270,839 units | null | 3012150451 | 1 | 0 | No Action Indicated (NAI) | 2021-10-25 | 0 | 0 | null | false | 0 | sterility | compromised package seals |
Z-2483-2024 | device | GE Medical Systems, LLC | SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR seque... | Ongoing | null | 2024-06-14 | 2024-08-14 | null | 3 units | null | 1000116747 | 1 | 0 | No Action Indicated (NAI) | 2016-10-11 | 0 | 0 | null | false | 0 | device_malfunction | SAR limit exceed |
Z-1847-2013 | device | Hospira Inc. | The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. | The devices secondary audio signal fails to activate. | Terminated | null | 2013-02-04 | 2013-08-07 | null | 2,791 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | audio signal failure |
D-0539-2016 | drug | Walgreens Infusion Services | Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Terminated | null | 2015-11-10 | 2016-01-06 | Texas | 46 Minibags | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-1816-2025 | device | Baxter Healthcare Corporation | Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P... | There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed. | Ongoing | null | 2025-05-06 | 2025-06-04 | null | 164 units | null | 1417572 | 11 | 1 | No Action Indicated (NAI) | 2024-02-06 | 1 | 1 | 2009-09-10 | false | 0 | device_malfunction | improper wire crimp |
Z-0994-2020 | device | Cardinal Health 200, LLC | Genius 2 Tympanic Thermometer Private Label Item Code: 3069 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermome... | Terminated | null | 2019-10-28 | 2020-02-12 | null | in total 37567 units US; 335573 OUS | null | 2016452 | 3 | 0 | No Action Indicated (NAI) | 2021-12-21 | 0 | 0 | null | false | -1 | device_malfunction | calibration drift accuracy |
Z-2442-2018 | device | Intel-GE Care Innovations LLC | Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Har... | It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days. | Terminated | null | 2017-12-06 | 2018-07-25 | null | 1302 | null | 3008846825 | 1 | 0 | No Action Indicated (NAI) | 2011-10-21 | 0 | 0 | null | false | 0 | software | data sync delay |
D-0884-2021 | drug | Washington Homeopathic Products, Inc. | Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, R... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Terminated | null | 2021-08-20 | 2021-10-06 | Distributed Nationwide in the USA | 2/1 Liter bottle | null | 3006489197 | 10 | 4 | Voluntary Action Indicated (VAI) | 2023-08-23 | 3 | 3 | 2020-06-19 | false | -1 | potency | failed identification testing |
Z-2298-2018 | device | Howmedica Osteonics Corp. | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | Terminated | null | 2018-05-22 | 2018-07-11 | null | null | 3003070421 | 7 | 0 | Voluntary Action Indicated (VAI) | 2023-12-01 | 0 | 0 | null | false | -1 | device_malfunction | femoral head disassociation | |
Z-2079-2014 | device | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measure... | RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) | Terminated | null | 2014-05-23 | 2014-07-30 | null | 20,507 cartridges | null | 3002637618 | 3 | 0 | No Action Indicated (NAI) | 2021-08-19 | 0 | 0 | null | false | -1 | device_malfunction | electrolyte measurement error |
Z-0426-2016 | device | bioMerieux, Inc. | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. | Terminated | null | 2015-11-03 | 2015-12-23 | null | 626 systems in total | null | 3002769706 | 4 | 2 | No Action Indicated (NAI) | 2017-04-10 | 1 | 1 | 2012-08-23 | false | -1 | software | patient record linkage |
Z-1819-2025 | device | GE Medical Systems, LLC | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures. | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Ongoing | null | 2025-03-21 | 2025-06-18 | null | Total for both products: 3472 (2,919 US; 553 OUS) | null | 1000116747 | 1 | 0 | No Action Indicated (NAI) | 2016-10-11 | 0 | 0 | null | false | 0 | device_malfunction | X-ray field calibration |
D-0030-2024 | drug | Central Admixture Pharmacy Services Inc | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2 | Lack of assurance of sterility: | Terminated | null | 2023-09-21 | 2023-10-11 | Nationwide in the USA | 274 30 mL syringes | null | 3005292119 | 1 | 0 | Voluntary Action Indicated (VAI) | 2021-05-24 | 0 | 0 | null | false | 0 | sterility | sterility assurance failure |
Z-0670-2013 | device | Terumo Cardiovascular Systems Corporation | Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the asc... | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufact... | Terminated | null | 2013-01-07 | 2013-01-23 | null | 6830 total all products | null | 3000204839 | 6 | 0 | No Action Indicated (NAI) | 2024-02-16 | 0 | 0 | null | false | -1 | device_malfunction | flash defect connector |
D-0718-2023 | drug | Central Admixture Pharmacy Services, Inc. | vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1. | 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. | 3075 bags | null | 3009590582 | 4 | 3 | Official Action Indicated (OAI) | 2023-03-30 | 3 | 3 | 2024-03-29 | true | 0 | sterility | sterility assurance failure |
Z-1854-2017 | device | Smith & Nephew, Inc. | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | Terminated | null | 2017-03-09 | 2017-04-26 | null | 1 unit | null | 1219602 | 3 | 0 | No Action Indicated (NAI) | 2017-05-25 | 0 | 0 | null | false | -1 | mislabeling | incorrect expiration date |
Z-1739-2024 | device | Cardinal Health 200, LLC | Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | Ongoing | null | 2024-03-27 | 2024-05-08 | null | 98 cases of 12 | null | 3002973487 | 3 | 0 | No Action Indicated (NAI) | 2015-07-20 | 0 | 0 | null | false | 0 | sterility | non-sterilized product |
Z-2599-2023 | device | Stryker Corporation | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000 | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site | Ongoing | null | 2023-08-07 | 2023-09-27 | null | 8 units US | null | 3015967359 | 1 | 0 | Voluntary Action Indicated (VAI) | 2023-01-24 | 0 | 0 | null | false | 0 | device_malfunction | femoral nozzle breakage |
Z-1816-2021 | device | Alphatec Spine, Inc. | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Terminated | null | 2021-04-26 | 2021-06-16 | null | N/A | null | 2027467 | 8 | 2 | No Action Indicated (NAI) | 2022-07-18 | 3 | 3 | 2015-07-16 | false | -1 | device_malfunction | screw mechanism failure |
Z-0915-2022 | device | Boston Scientific Corporation | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy | Pouch seals may be open, compromising sterility. | Ongoing | null | 2022-03-08 | 2022-04-20 | null | 433 5-packs | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | 0 | sterility | open pouch seals |
D-0636-2019 | drug | King Bio Inc. | Dr. King's Natural Medicine Homeopathic Ear Ringing, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955527527, NDC 57955-5275-2 | Microbial contamination | Terminated | null | 2018-07-20 | 2019-03-20 | U.S.A. Nationwide, Canada, and Australia. | 1980 bottles | null | 1053442 | 8 | 1 | Voluntary Action Indicated (VAI) | 2023-07-28 | 2 | 2 | 2019-03-20 | false | -1 | contamination | microbial contamination |
Z-3386-2018 | device | B. Braun Medical, Inc. | GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous admi... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 1020 | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | -1 | device_malfunction | connector failure |
Z-0453-2021 | device | Cardinal Health 200, LLC | Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product. | The feeding spike sets may leak at the interface of the tube and spike connector. | Ongoing | null | 2020-09-22 | 2020-11-25 | null | 197370 | null | 3034315018 | 1 | 0 | No Action Indicated (NAI) | 2025-09-18 | 0 | 0 | null | false | -1 | device_malfunction | leaking connector interface |
Z-1261-2020 | device | Siemens Healthcare Diagnostics, Inc. | Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay | Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer. | Terminated | null | 2019-11-19 | 2020-02-26 | null | 1306 | null | 1219913 | 8 | 1 | Voluntary Action Indicated (VAI) | 2022-03-08 | 1 | 1 | 2012-05-10 | false | -1 | device_malfunction | calibrator defect |
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