[ 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 |
|---|---|---|---|---|
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2186-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2138-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2142-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2144-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2199-2026 | Incomplete seals on sterile product | 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-2189-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2180-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2183-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2145-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 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 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-2194-2026 | 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 | Stryker Sustainability SolutionsZ-2197-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2184-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | FINESALER LLCH-0773-2026 | Product may contain foreign objects, specifically glass. | Environmental Monitoring |
| 2026-05-20 | Class I | Sugar Foods LLCH-0781-2026 | Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella. | 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-2198-2026 | 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 | Dakota Honey CompanyH-0772-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2195-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2188-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2139-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 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.