[ 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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1,158 matching recalls
DateClassFirmReasonQuality domain
2026-04-29Class IIMagellan Diagnostics, Inc.Z-1893-2026Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.—
2026-04-29Class IIBeckman Coulter, Inc.Z-1922-2026Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1888-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
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 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 IIARROW INTERNATIONAL, LLCZ-1911-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1914-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1830-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
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 IIMedline Industries, LPZ-1841-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
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 IIMedline Industries, LPZ-1887-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIFoundation Medicine, Inc.Z-1937-2026Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.—
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 IIARROW INTERNATIONAL, LLCZ-1913-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1877-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1882-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1912-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIIntegra LifeSciences Corp. (NeuroSciences)Z-1828-2026Software issue that renders the touch screen unresponsive.—
2026-04-29Class IIMagellan Diagnostics, Inc.Z-1895-2026Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.—
2026-04-29Class IIMedline Industries, LPZ-1845-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
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 IIMedline Industries, LPZ-1889-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IILSL Healthcare Inc.Z-1929-2026Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.Environmental Monitoring
2026-04-29Class IIMedline Industries, LPZ-1833-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
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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.