[ 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.

1,158 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-07-22	Class I	Abiomed, Inc.Z-2686-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class II	Orthofix U.S. LLCZ-2731-2026	Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111	Documentation & Change Control
2026-07-22	Class II	Olympus Corporation of the AmericasZ-2721-2026	Some 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
2026-07-22	Class II	Medline Industries, LPZ-2736-2026	Kits 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
2026-07-22	Class I	Argon Medical Devices, IncZ-2704-2026	Kits 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
2026-07-22	Class I	Oscor Inc.Z-2679-2026	Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.	Risk Management & CAPA
2026-07-22	Class I	Argon Medical Devices, IncZ-2706-2026	Kits 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
2026-07-22	Class II	Olympus Corporation of the AmericasZ-2718-2026	Some 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
2026-07-22	Class II	Daavlin Distributing CompanyZ-2743-2026	Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).	Documentation & Change Control
2026-07-22	Class I	Abiomed, Inc.Z-2692-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class I	Abiomed, Inc.Z-2683-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class II	ICU Medical, Inc.Z-2723-2026	In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.	—
2026-07-22	Class II	Tosoh Bioscience IncZ-2746-2026	The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.	Validation & Qualification
2026-07-22	Class II	GE Medical Systems, LLCZ-2726-2026	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.	—
2026-07-22	Class II	Boston Scientific CorporationZ-2725-2026	Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.	—
2026-07-22	Class II	Daavlin Distributing CompanyZ-2742-2026	Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).	Documentation & Change Control
2026-07-22	Class I	Abiomed, Inc.Z-2693-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class II	GE Medical Systems, LLCZ-2728-2026	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.	—
2026-07-22	Class I	Abiomed, Inc.Z-2685-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class I	Argon Medical Devices, IncZ-2708-2026	Kits 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
2026-07-22	Class I	Abiomed, Inc.Z-2682-2026	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.	Risk Management & CAPA
2026-07-22	Class II	Papablic IncZ-2734-2026	Potential for brush heads to break.	—
2026-07-22	Class II	GE Medical Systems, LLCZ-2727-2026	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.	—
2026-07-22	Class II	Daavlin Distributing CompanyZ-2744-2026	Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).	Documentation & Change Control
2026-07-22	Class II	Medtronic Perfusion SystemsZ-2739-2026	Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.	Environmental 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.