[ 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.
1,158 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2181-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Medtronic NeuromodulationZ-2201-2026 | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all. | — |
| 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 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-2185-2026 | 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 | 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 | GE Medical Systems, LLCZ-2149-2026 | 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 | Stryker Sustainability SolutionsZ-2191-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 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-2182-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Medline Industries, LPZ-2147-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2175-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2178-2026 | Incomplete seals on sterile product | 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-2140-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2193-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2196-2026 | 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 | GE Medical Systems, LLCZ-2150-2026 | 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 | DJO, LLCZ-2137-2026 | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | — |
| 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 II | Stryker Sustainability SolutionsZ-2179-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2190-2026 | Incomplete seals on sterile product | 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.