[ 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 |
|---|---|---|---|---|
| 2026-03-25 | Class II | Stryker Medical Division of Stryker CorporationZ-1580-2026 | Cribs sold in the USA are missing two access door warning labels. | Documentation & Change Control |
| 2026-03-25 | Class II | LeMaitre Vascular, Inc.Z-1574-2026 | Labeling mix-up resulting in the incorrect lot outer packaging of product. | Documentation & Change Control |
| 2026-03-25 | Class II | ConvaTec, IncZ-1583-2026 | Drainable large pouch may leak due to manufacturing issue. | Risk Management & CAPA |
| 2026-03-25 | Class II | ConvaTec, IncZ-1582-2026 | Drainable large pouch may leak due to manufacturing issue. | Risk Management & CAPA |
| 2026-03-25 | Class II | Diagnostica Stago, Inc.Z-1585-2026 | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. | — |
| 2026-03-25 | Class II | GE Medical Systems, LLCZ-1570-2026 | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. | Data Integrity |
| 2026-03-25 | Class II | Elekta, Inc.Z-1581-2026 | Due to adapter not being properly aligned or locked in place. | — |
| 2026-03-25 | Class III | Datascope Corp.Z-1587-2026 | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue. | — |
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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.