This dataset requires a paid license. Please purchase access at the link below and provide your Hugging Face username. Once purchased, submit an access request on this page. Access is granted manually.

FDA Device Recall Events Dataset

This dataset consolidates FDA medical device enforcement recall records from 2012-2026.

Each row represents one FDA device recall record with normalized dates, severity information, manufacturer geography, distribution scope, quantity parsing, and operational keyword flags that make the raw enforcement feed easier to use for compliance monitoring, supplier risk review, procurement screening, and healthcare market research.

The source data is collected directly from the FDA device enforcement API using year-partitioned paging so the full corpus can be reproduced without truncating at the API skip limit.

Dataset Preview

recall_record_id	event_id	recall_number	status	classification	classification_rank	product_type	recalling_firm	firm_slug	address_1	city	state	country	postal_code	voluntary_mandated	initial_firm_notification	distribution_pattern	distribution_scope	international_distribution	product_description	product_quantity	product_quantity_value	product_quantity_unit	reason_for_recall	code_info	more_code_info	recall_initiation_date	center_classification_date	report_date	days_to_classification	days_to_report	report_year	report_month	has_openfda_metadata	keyword_software	keyword_labeling	keyword_sterility	keyword_packaging	keyword_power_battery	keyword_contamination	source_url	source_domain	last_collected_at
98750__Z-2201-2026	98750	Z-2201-2026	Ongoing	Class II	2	Devices	Medtronic Neuromodulation	medtronic-neuromodulation	7000 Central Ave Ne	Minneapolis	MN	United States	55432-3568	Voluntary: Firm initiated	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit	Worldwide distribution.	international	True	Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on... [425 more chars]	10165 units	10165.0	units	Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the... [269 more chars]	Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900... [32,480 more chars]	NPL3018840, NPL3018842, NPL3018843, NPL3018844, NPL3018892, NPL3018894, NPL3019405, NPL3019406, NPL3... [89,961 more chars]	2026-04-08 00:00:00+00:00	2026-05-14 00:00:00+00:00	2026-05-20 00:00:00+00:00	36	42	2026	5	False	True	False	False	False	False	False	https://api.fda.gov/device/enforcement.json?search=event_id%3A%2298750%22%20AND%20recall_number%3A%2... [23 more chars]	api.fda.gov	2026-05-30 19:42:45+00:00
98755__Z-2200-2026	98755	Z-2200-2026	Ongoing	Class II	2	Devices	MICROVENTION INC.	microvention-inc	35 Enterprise	Aliso Viejo	CA	United States	92656	Voluntary: Firm initiated		International distribution to the country of China.	international	True	LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 2140... [99 more chars]	38	38.0		Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconfor... [290 more chars]	Lots: 0000616462, 0000619851, 0000552987, 0000551725. UDI: (01)00842429115893(11)240325(17)270228(10... [552 more chars]		2026-04-06 00:00:00+00:00	2026-05-14 00:00:00+00:00	2026-05-20 00:00:00+00:00	38	44	2026	5	False	False	False	False	False	False	False	https://api.fda.gov/device/enforcement.json?search=event_id%3A%2298755%22%20AND%20recall_number%3A%2... [23 more chars]	api.fda.gov	2026-05-30 19:42:45+00:00
98633__Z-2172-2026	98633	Z-2172-2026	Ongoing	Class II	2	Devices	Edwards Lifesciences, LLC	edwards-lifesciences-llc	1 Edwards Way	Irvine	CA	United States	92614-5688	Voluntary: Firm initiated	E-Mail	Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID... [192 more chars]	international	True	Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO				Labeling update to provide warning if functionality of the valve replacement delivery system is comp... [8 more chars]	All Lots/UDI:0690103D004EVD000V5		2026-03-27 00:00:00+00:00	2026-05-13 00:00:00+00:00	2026-05-20 00:00:00+00:00	47	54	2026	5	False	False	True	True	False	False	False	https://api.fda.gov/device/enforcement.json?search=event_id%3A%2298633%22%20AND%20recall_number%3A%2... [23 more chars]	api.fda.gov	2026-05-30 19:42:45+00:00
98708__Z-2174-2026	98708	Z-2174-2026	Ongoing	Class II	2	Devices	Stryker Sustainability Solutions	stryker-sustainability-solutions	1810 W Drake Dr	Tempe	AZ	United States	85283-4327	Voluntary: Firm initiated		US Nationwide and the countries of Israel and Canada.	us_nationwide	False	BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER	3063 units	3063.0	units	Incomplete seals on sterile product	UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881... [23,458 more chars]		2026-04-10 00:00:00+00:00	2026-05-13 00:00:00+00:00	2026-05-20 00:00:00+00:00	33	40	2026	5	False	False	False	True	False	False	False	https://api.fda.gov/device/enforcement.json?search=event_id%3A%2298708%22%20AND%20recall_number%3A%2... [23 more chars]	api.fda.gov	2026-05-30 19:42:45+00:00
98708__Z-2175-2026	98708	Z-2175-2026	Ongoing	Class II	2	Devices	Stryker Sustainability Solutions	stryker-sustainability-solutions	1810 W Drake Dr	Tempe	AZ	United States	85283-4327	Voluntary: Firm initiated		US Nationwide and the countries of Israel and Canada.	us_nationwide	False	BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER	61 units	61.0	units	Incomplete seals on sterile product	UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056... [364 more chars]		2026-04-10 00:00:00+00:00	2026-05-13 00:00:00+00:00	2026-05-20 00:00:00+00:00	33	40	2026	5	False	False	False	True	False	False	False	https://api.fda.gov/device/enforcement.json?search=event_id%3A%2298708%22%20AND%20recall_number%3A%2... [23 more chars]	api.fda.gov	2026-05-30 19:42:45+00:00

Access Requirements (Paid Dataset)

This dataset is behind manual gated access.

To obtain access:

Purchase the dataset here:
https://masonmarker.gumroad.com/l/fda-device-recall-events
Provide your Hugging Face username at checkout.
Return to this Hugging Face page and click:
"Request Access"
Your access will be approved within 1-12 hours.

Once approved, you can use the Python snippet at the bottom of this README to load the dataset.

Dataset Structure

Total rows: 39,053

Total columns: 46

Splits

data: 39,053 rows

Data Files

data: data/data.parquet

Data Dictionary

The table below describes the columns included in this dataset.

column	pandas_dtype	dataset_type	description
recall_record_id	string	string	Text column. Stable unique identifier for the recall row generated from the FDA event id and recall number.
event_id	string	integer-like string	Stored as text, but values appear to represent whole numbers. FDA event identifier associated with the recall.
recall_number	string	string	Text column. FDA recall number for the enforcement record.
status	string	string	Text column. Current FDA status for the recall record, such as ongoing or terminated.
classification	string	string	Text column. FDA recall classification level indicating severity, such as Class I, Class II, or Class III.
classification_rank	Int64	integer	Whole-number numeric column. Numeric severity rank derived from classification where a higher value indicates higher risk.
product_type	string	string	Text column. Top-level FDA product domain for the recall record.
recalling_firm	string	string	Text column. Name of the manufacturer, distributor, or responsible firm identified in the recall.
firm_slug	string	string	Text column. Normalized slug version of the recalling firm name for easier grouping and joins.
address_1	string	string	Text column. Primary street address line for the recalling firm when provided by the FDA record.
address_2	string	string	Text column. Secondary street address line for the recalling firm when provided by the FDA record.
city	string	string	Text column. City listed for the recalling firm.
state	string	string	Text column. State or province listed for the recalling firm.
country	string	string	Text column. Country listed for the recalling firm.
postal_code	string	string	Text column. Postal code listed for the recalling firm.
voluntary_mandated	string	string	Text column. FDA text indicating whether the recall was voluntary or mandated.
initial_firm_notification	string	string	Text column. Method the recalling firm used for initial notification, such as letter or telephone.
distribution_pattern	string	long text	Free-text column containing longer text values. Raw FDA distribution pattern text describing where affected products were distributed.
distribution_scope	string	string	Text column. Normalized distribution scope derived from the raw distribution pattern text.
international_distribution	boolean	boolean	True/false column. Boolean flag indicating whether the distribution pattern mentions foreign or international distribution.
product_description	string	long text	Free-text column containing longer text values. FDA product description for the recalled device.
product_quantity	string	string	Text column. Raw quantity text supplied in the FDA record.
product_quantity_value	float64	float	Decimal numeric column. Parsed numeric quantity extracted from the raw product quantity text when available.
product_quantity_unit	string	string	Text column. Unit text remaining after extracting the numeric quantity value.
reason_for_recall	string	long text	Free-text column containing longer text values. FDA narrative describing why the device was recalled.
code_info	string	long text	Free-text column containing longer text values. FDA code information field, often containing model, lot, catalog, or GTIN details.
more_code_info	string	long text	Free-text column containing longer text values. Additional FDA code information when present.
recall_initiation_date	datetime64[ns, UTC]	datetime	Date or timestamp column. Date the recall was initiated.
center_classification_date	datetime64[ns, UTC]	datetime	Date or timestamp column. Date the FDA center assigned the official recall classification.
report_date	datetime64[ns, UTC]	datetime	Date or timestamp column. Date the recall record was reported in the enforcement feed.
termination_date	datetime64[ns, UTC]	datetime	Date or timestamp column. Date the recall was terminated when available.
days_to_classification	Int64	integer	Whole-number numeric column. Number of days between recall initiation and center classification.
days_to_report	Int64	integer	Whole-number numeric column. Number of days between recall initiation and report date.
days_to_termination	Int64	integer	Whole-number numeric column. Number of days between recall initiation and termination date when available.
report_year	Int64	integer	Whole-number numeric column. Calendar year extracted from the report date.
report_month	Int64	integer	Whole-number numeric column. Calendar month extracted from the report date.
has_openfda_metadata	boolean	boolean	True/false column. Boolean flag indicating whether the record included an `openfda` payload.
keyword_software	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions software, firmware, or cybersecurity concepts.
keyword_labeling	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions labeling, instructions, directions, or IFU concepts.
keyword_sterility	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions sterility or sterilization issues.
keyword_packaging	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions packaging, seal, pouch, or container issues.
keyword_power_battery	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions battery, charging, electrical, or power issues.
keyword_contamination	boolean	boolean	True/false column. Boolean flag indicating that the recall text mentions contamination, particulate, debris, or foreign matter issues.
source_url	string	long text	Free-text column containing longer text values. Row-level FDA API URL that can be used to retrieve the underlying recall record.
source_domain	string	string	Text column. Domain name of the source system used for the row.
last_collected_at	datetime64[ns, UTC]	datetime	Date or timestamp column. UTC timestamp when the dataset build collected the row.

Intended Use

This dataset is intended for research, experimentation, analysis, and model prototyping.

Loading the Dataset


import os
from datasets import load_dataset

HUGGINGFACE_API_KEY = os.environ.get("HUGGINGFACE_API_KEY")

dataset = load_dataset(
    "masonmarker/fda-device-recall-events",
    token=HUGGINGFACE_API_KEY,
)

print(dataset)
print(dataset[list(dataset.keys())[0]][0])

# getting the DataFrame itself
# df = dataset[list(dataset.keys())[0]].to_pandas()

Marker, Mason. (2025). FDA Device Recall Events Dataset. Hugging Face. https://huggingface.co/datasets/masonmarker/fda-device-recall-events

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