[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
1,235 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2218-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2215-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class I | JOHN B SANFILIPPO & SONS INCH-0835-2026 | potential presence of Salmonella | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2186-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Pure Ground Ingredients, Inc.H-0853-2026 | Product has the potential to be contaminated with Salmonella. | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0768-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2174-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2192-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2143-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Oasis Medical, Inc.D-0525-2026 | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2185-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2146-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2184-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2177-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0771-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2176-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2148-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2181-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0769-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2141-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2187-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2198-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0770-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2191-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0772-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.