[ 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
2026-05-13Class IIMedline Industries, LPZ-2093-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2116-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2090-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2117-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIIFalcon Trading Co., Inc.H-0695-2026Potential contamination with pesticides, haloxyfop and thiamethoxamEnvironmental Monitoring
2026-05-13Class IRaw Farm LLCH-0765-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class IRaw Farm LLCH-0762-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2096-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2115-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2111-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2113-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2129-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2119-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2104-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IICareFusion 213, LLCD-0518-2026Lack of assurance of Sterility: potential product contaminationEnvironmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2109-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2128-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2101-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2099-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2098-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIFresenius Medical Care Holdings, Inc.D-0512-2026Lack of Assurance of Sterility: Potential leaks from perforations in bags.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2091-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIAcella Pharmaceuticals, LLCD-0523-2026Chemical contamination; presence of lead and lithium above specificationEnvironmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2108-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIIFalcon Trading Co., Inc.H-0697-2026Potential contamination with pesticides, haloxyfop and thiamethoxamEnvironmental 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.