[ 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 IIOlympus Corporation of the AmericasZ-1899-2026Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.Risk Management & CAPA
2026-04-29Class IIUvlizer c/o RAIS INTERNATIONAL LLCZ-1808-2026In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.—
2026-04-29Class IIDiversatek HealthcareZ-1939-2026The 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 IIDiversatek HealthcareZ-1941-2026The 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 IIAngiodynamics, Inc.Z-1869-2026The 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 IISurgiSmoke SolutionsZ-1926-2026Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.Environmental Monitoring
2026-04-29Class IIUvlizer c/o RAIS INTERNATIONAL LLCZ-1807-2026In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.—
2026-04-29Class IIAngiodynamics, Inc.Z-1867-2026The 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-1837-2026The 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-1865-2026The 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-1874-2026The 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-1910-2026Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufacturedDocumentation & Change Control
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
2026-04-29Class IIWindstone Medical Packaging, Inc.Z-1919-2026The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).—
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1917-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1891-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIFoundation Medicine, Inc.Z-1927-2026Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants—
2026-04-29Class IIMedline Industries, LPZ-1832-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIRemel Europe Ltd.Z-1923-2026Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.Environmental Monitoring
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 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 IIXTANT Medical Holdings, IncZ-1897-2026Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.Validation & Qualification
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 IIMedline Industries, LPZ-1848-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIDiversatek HealthcareZ-1938-2026The 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
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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.