[ 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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409 matching recalls
DateClassFirmReasonQuality domain
2026-07-08Class IIBard Access Systems, Inc.Z-2658-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2662-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IInsulet CorporationZ-2603-2026External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2660-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2655-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2665-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2659-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2544-2026The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2543-2026The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2610-2026Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2541-2026The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2534-2026The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.Risk Management & CAPA
2026-07-08Class IMedtronic Heart Valves DivisionZ-2624-2026Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2666-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIMedline Industries, LPZ-2611-2026Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
2026-07-08Class IIBard Access Systems, Inc.Z-2663-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-01Class IIAmgen, Inc.D-0614-2026CGMP DeviationsRisk Management & CAPA
2026-07-01Class IISURGIFY MEDICAL OYZ-2572-2026Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Risk Management & CAPA
2026-07-01Class IIZimmer, Inc.Z-2531-2026Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.Risk Management & CAPA
2026-07-01Class IISURGIFY MEDICAL OYZ-2565-2026Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Risk Management & CAPA
2026-07-01Class IIZimmer, Inc.Z-2528-2026Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.Risk Management & CAPA
2026-07-01Class IISURGIFY MEDICAL OYZ-2561-2026Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Risk Management & CAPA
2026-07-01Class IISURGIFY MEDICAL OYZ-2566-2026Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Risk Management & CAPA
2026-07-01Class IIAmgen, Inc.D-0613-2026CGMP DeviationsRisk Management & CAPA
2026-07-01Class IISURGIFY MEDICAL OYZ-2568-2026Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Risk Management & CAPA
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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.