[ 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 IIMedline Industries, LPZ-1885-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1878-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIOlympus Corporation of the AmericasZ-1854-2026Potential for detachment of a distal tip component of the device during use.—
2026-04-29Class IIMedline Industries, LPZ-1829-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control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-1903-2026XXX—
2026-04-29Class IILSL Healthcare Inc.Z-1933-2026Medical 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-1835-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1884-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
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 IILSL Healthcare Inc.Z-1930-2026Medical 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-1883-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
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 IIOlympus Corporation of the AmericasZ-1851-2026Potential for detachment of a distal tip component of the device during use.—
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1916-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
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 IIMagellan Diagnostics, Inc.Z-1894-2026Customers 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 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 IIMedline Industries, LPZ-1847-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1836-2026The 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-1901-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IISurgiSmoke SolutionsZ-1924-2026Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.Environmental Monitoring
2026-04-29Class IIMedline Industries, LPZ-1839-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1886-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
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 IIMedline Industries, LPZ-1892-2026Unapproved design changes to the products outside of the 510(k) clearance.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.