[ 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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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-05-06Class IILACTALIS CANADA, INCH-0680-2026Product may contain foreign objects, specifically glass.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2008-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2029-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2018-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2044-2026Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.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 IILSL Healthcare Inc.Z-1932-2026Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.Environmental Monitoring
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
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-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 IIB BRAUN MEDICAL INCD-0498-2026Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Environmental Monitoring
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 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 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 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 IIB BRAUN MEDICAL INCD-0497-2026Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Environmental Monitoring
2026-04-29Class IIB BRAUN MEDICAL INCD-0496-2026Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Environmental Monitoring
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 IIB BRAUN MEDICAL INCD-0495-2026Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Environmental Monitoring
2026-04-29Class IIHarrow Eye LLCD-0489-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-04-29Class IUnistel Industries Inc.H-0666-2026Product may be contaminated with Salmonella.Environmental Monitoring
2026-04-22Class IIHuons Co., Ltd.D-0529-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-04-22Class IIOwen Biosciences Inc.D-0453-2026Chemical contamination: Presence of benzeneEnvironmental Monitoring
2026-04-22Class IIOwen Biosciences Inc.D-0454-2026Chemical contamination: Presence of benzeneEnvironmental Monitoring
2026-04-22Class IIInternational Medication Systems Ltd.D-0483-2026Lack of Assurance of SterilityEnvironmental 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.