[ 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-1840-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control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-1906-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IILSL Healthcare Inc.Z-1928-2026Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.Environmental Monitoring
2026-04-29Class IISurgiSmoke SolutionsZ-1925-2026Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.Environmental Monitoring
2026-04-29Class IIDavol, Inc.Z-1896-2026Potential for product to contain foreign matter, confirmed to be inspect fragments.—
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 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 IIARROW INTERNATIONAL, LLCZ-1915-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
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 IIMedline Industries, LPZ-1850-2026The 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-1853-2026Potential for detachment of a distal tip component of the device during use.—
2026-04-29Class IIMedline Industries, LPZ-1849-2026The 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-1900-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIMedline Industries, LPZ-1842-2026The 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-1831-2026The 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-1846-2026The 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-1905-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIDiversatek HealthcareZ-1940-2026The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1880-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1879-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIOlympus Corporation of the AmericasZ-1898-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIOlympus Corporation of the AmericasZ-1852-2026Potential for detachment of a distal tip component of the device during use.—
2026-04-29Class IIMedline Industries, LPZ-1843-2026The 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-1890-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IILSL Healthcare Inc.Z-1931-2026Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.Environmental Monitoring
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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.