[ 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 I | Omnicell, Inc.Z-2047-2026 | Potential for mislabeled syringe produced by the i.v.STATION device. | Documentation & Change Control |
| 2026-05-20 | Class II | Hologic, IncZ-2167-2026 | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | — |
| 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 | 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 | FINESALER LLCH-0773-2026 | Product may contain foreign objects, specifically glass. | Environmental Monitoring |
| 2026-05-20 | Class I | ARROW INTERNATIONAL, LLCZ-2156-2026 | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. | — |
| 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 | Dexcom, Inc.Z-2163-2026 | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. | Data Integrity |
| 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-2153-2026 | 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 | 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.