[ 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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2198-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2197-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Prospector Popcorn, LLCH-0779-2026 | Products contain undeclared soy, specifically soy lecithin. | Documentation & Change Control |
| 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 | Technological Medical Advancements LLCZ-2162-2026 | Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W. | Data Integrity |
| 2026-05-20 | Class II | Ferris Coffee and Nut Company, Inc.H-0774-2026 | Undeclared allergens (wheat and soy). | Documentation & Change Control |
| 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-0772-2026 | 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 II | FINESALER LLCH-0773-2026 | Product may contain foreign objects, specifically glass. | Environmental Monitoring |
| 2026-05-20 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2170-2026 | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. | — |
| 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-0768-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Ocinet, Inc.H-0780-2026 | Undeclared allergen ingredient (fish) | Documentation & Change Control |
| 2026-05-20 | Class II | Raja Foods and Vegetables Inc.H-0777-2026 | Contains undeclared FD&C Yellow 6 | Documentation & Change Control |
| 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 | GE Medical Systems, LLCZ-2154-2026 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. | Data Integrity |
| 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 | WE R NUTSH-0775-2026 | Contains undeclared allergens (cashews, milk, and soy). | Documentation & Change Control |
| 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 | GE Medical Systems, LLCZ-2152-2026 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. | Data Integrity |
| 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 II | Ascend Laboratories, LLCD-0547-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2026-05-20 | Class II | ENDO USA, Inc.D-0527-2026 | Crystallization; identified as Buprenorphine free base | — |
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.