Dataset
FDA Medical Device Recall Enforcement Quarterly Archive
Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.
Not Yet Published
Marketplace Availability
Application coverage and provider review state are shown separately from public product destinations.
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Who It Is For
- Teams that need repeatable public-data monitoring without manual copy-paste workflows.
- Builders packaging public signals into datasets, APIs, automation, or agent tools.
- Operators who need a reliable way to inspect, compare, and use public-data products.
Problems Solved
- Turns source-specific public information into a normalized product profile.
- Helps teams compare product output before opening a marketplace destination.
- Supports repeatable research, monitoring, alerting, and workflow delivery.
Marketplace Fit
Useful for teams that want packaged data, API, automation, or AI-tool delivery.
Fda Device Recall Enforcement Record sample rows
Example fields available for buyer review.
| Field | Example value |
|---|---|
| state | IL |
| status | Ongoing |
| country | United States |
| source_url | https://api.fda.gov/device/enforcement.json?search=recall_number.exact%3A%22Z-2537-2026%22&limit=1 |
| report_date | 20260708 |
| recall_number | Z-2537-2026 |
| classification | Class II |
| recalling_firm | Medline Industries, LP |
| product_quantity | 333 kits |
| reason_for_recall | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. |
| voluntary_mandated | Voluntary: Firm initiated |
| product_description | Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK |
| distribution_pattern | US Nationwide distribution. |
| recall_initiation_date | 20260521 |
Schema Preview
recall_numberstring - Recall number.
report_datestring - Report date.
recall_initiation_datestring - Recall initiation date.
classificationstring - Classification.
statusstring - Status.
recalling_firmstring - Recalling firm.
product_descriptionstring - Product description.
reason_for_recallstring - Reason for recall.
product_quantitystring - Product quantity.
distribution_patternstring - Distribution pattern.
voluntary_mandatedstring - Voluntary mandated.
countrystring - Country.
statestring - State.
source_urlstring - Source url.
Pricing Events
Pricing is shown by the external marketplace when a public listing is available.
What You Can Review
- Sample output is available.
- Schema preview includes 14 fields.
- No public marketplace destination is published yet.
Data Notes
- Product details are based on the current public catalog.
- Samples and schemas are shown when available for buyer review.