[ 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
2026-07-22Class IIGELLERT GLOBAL GROUPH-1176-2026Foreign material (Glass) was found in the product.Environmental Monitoring
2026-07-22Class IICareFusion 213, LLCD-0690-2026Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicatorEnvironmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2709-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2707-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-22Class IIMedtronic Perfusion SystemsZ-2739-2026Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.Environmental Monitoring
2026-07-22Class IIMedline Industries, LPZ-2737-2026Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.Environmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2708-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-22Class IIMedtronic Perfusion SystemsZ-2738-2026Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.Environmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2705-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-22Class IIOlympus Corporation of the AmericasZ-2718-2026Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.Environmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2704-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-22Class IIMedline Industries, LPZ-2736-2026Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.Environmental Monitoring
2026-07-22Class IIOlympus Corporation of the AmericasZ-2719-2026Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.Environmental Monitoring
2026-07-22Class IIMaquet Cardiovascular, LLCZ-2741-2026Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.Environmental Monitoring
2026-07-22Class IIChiesi USA, Inc.D-0689-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.H-1181-2026Potential E. coli O145:H28 ContaminationEnvironmental Monitoring
2026-07-22Class IIGeneral Mills James Ford Bell Technical CenterH-1154-2026Potential foreign material (glass)Environmental Monitoring
2026-07-22Class IIW.Y. Industries, Inc.H-1157-2026Product may contain metal fragments.Environmental Monitoring
2026-07-22Class IIOlympus Corporation of the AmericasZ-2721-2026Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.Environmental Monitoring
2026-07-22Class IIOlympus Corporation of the AmericasZ-2720-2026Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.Environmental Monitoring
2026-07-22Class IIGeneral Mills James Ford Bell Technical CenterH-1155-2026Potential foreign material (glass)Environmental Monitoring
2026-07-22Class IArgon Medical Devices, IncZ-2706-2026Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.Environmental Monitoring
2026-07-15Class IIReliance Life Sciences Private LimitedD-0672-2026Lack of Sterility AssuranceEnvironmental Monitoring
2026-07-15Class IIWondermade LLCH-1147-2026Foreign material: small metal piecesEnvironmental Monitoring
2026-07-15Class IIReliance Life Sciences Private LimitedD-0674-2026Lack of Sterility AssuranceEnvironmental 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.