[ 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.

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409 matching recalls
DateClassFirmReasonQuality domain
2026-04-29Class IIOlympus Corporation of the AmericasZ-1900-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1856-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1870-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1875-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1906-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1908-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1860-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1858-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1902-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1907-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1871-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIMicro-X Ltd.Z-1918-2026X-Ray generator may malfunction resulting in the X-Ray being inoperable.Risk Management & CAPA
2026-04-29Class IILeading Pharma, LLCD-0486-2026CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1901-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1859-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1872-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1866-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1863-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1864-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1862-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1909-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1868-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1857-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIAngiodynamics, Inc.Z-1861-2026The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1904-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
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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.