[ 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-2681-2026 | 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 | 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 | 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 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 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 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 | 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 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 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 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 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 II | Olympus Corporation of the AmericasZ-2720-2026 | 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 | 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 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-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 | 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 | 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 | Maquet Cardiovascular, LLCZ-2741-2026 | Getinge 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 |
| 2026-07-22 | Class II | Medtronic Perfusion SystemsZ-2739-2026 | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | Environmental Monitoring |
| 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 | 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 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 |
| 2026-07-15 | Class II | Elekta, Inc.Z-2711-2026 | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | — |
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.