[ 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
2026-07-08Class IIMedline Industries, LPZ-2533-2026The 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 IIBoston Scientific CorporationZ-2629-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IIMedline Industries, LPZ-2607-2026Kits 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 IWindstone Medical Packaging, Inc.Z-2622-2026Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.Environmental Monitoring
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 IIMedline Industries, LPZ-2609-2026Kits 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 IITELEFLEX LLCZ-2639-2026Due to out-of-specification, or potential out-of-specification, levels of endotoxinsEnvironmental Monitoring
2026-07-08Class IIBard Access Systems, Inc.Z-2656-2026Due 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 IBaxter Healthcare CorporationZ-2548-2026There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.—
2026-07-08Class IIMedline Industries, LPZ-2538-2026The 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 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 IIMedline Industries, LPZ-2536-2026The 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 IIDEPUY (IRELAND)Z-2617-2026The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.Environmental Monitoring
2026-07-08Class IIAccuray IncorporatedZ-2640-2026In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.—
2026-07-08Class IIRemel, IncZ-2623-2026Reduced or no recovery of some strains of Neisseria gonorrhoeae.—
2026-07-08Class IIBard Access Systems, Inc.Z-2657-2026Due 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 IIRAYSEARCH LABORATORIES ABZ-2646-2026Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.—
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 IIZimmer Surgical IncZ-2674-2026Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.Environmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2632-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IISiemens Medical Solutions USA, IncZ-2641-2026Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.—
2026-07-08Class IMedline Industries, LPZ-2615-2026Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.Environmental Monitoring
2026-07-08Class IBaxter Healthcare CorporationZ-2550-2026There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.—
2026-07-08Class IInsulet CorporationZ-2604-2026External 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
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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.