[ 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 |
|---|---|---|---|---|
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2214-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2225-2026 | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. | — |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2219-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Becton, Dickinson and CompanyZ-2204-2026 | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Risk Management & CAPA |
| 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-2217-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2222-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Becton, Dickinson and CompanyZ-2202-2026 | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Risk Management & CAPA |
| 2026-05-27 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2227-2026 | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Validation & Qualification |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2220-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2177-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2176-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 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 | 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 I | Windstone Medical Packaging, Inc.Z-2066-2026 | Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism. | — |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2197-2026 | 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-2185-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2191-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | On-X Life Technologies, Inc.Z-2133-2026 | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. | — |
| 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 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 | 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. | — |
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.