Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

651–675 of 5027

SevereFDA (Devices)·Z-1679-2025·2025-05-14
Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports
Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.
Product
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1634-2025·2025-05-07
GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure
GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.
Product
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1633-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure
GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation modes or manual ventilation.
Product
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1629-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems may not ventilate effectively
Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.
Product
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1704-2025·2025-05-07
Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.
Product
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1695-2025·2025-05-07
Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.
Product
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-1696-2025·2025-05-07
Quantum Informatics VISION LIVE VUE Patient Monitor Recalled Without FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE patient monitoring software because it was marketed without required FDA clearance or approval.
Product
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clini
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-1637-2025·2025-05-07
GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect
GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.
Product
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1624-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.
Product
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1628-2025·2025-05-07
GE Healthcare Carestation 650 A1 Anesthesia System Ventilation
Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.
Product
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.
Product
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1702-2025·2025-05-07
Tibial Augment devices recalled for missing screw thread
Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.
Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1700-2025·2025-05-07
Posterior Femoral Augment with Missing Screw Thread Recalled
Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.
Product
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1630-2025·2025-05-07
GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.
Product
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1701-2025·2025-05-07
L-Shaped Femoral Augment with Missing Screw Thread
Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.
Product
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1699-2025·2025-05-07
Distal Femoral Augment medical device recall for defective screw
Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.
Product
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1632-2025·2025-05-07
GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall
GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.
Product
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1627-2025·2025-05-07
GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.
Product
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1638-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly
GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
Product
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1626-2025·2025-05-07
GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall
GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
Product
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1625-2025·2025-05-07
GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure
Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.
Product
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1635-2025·2025-05-07
GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure
Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.
Product
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1631-2025·2025-05-07
GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall
Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.
Product
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1643-2025·2025-04-30
Amplatzer TorqVue LP Delivery System Recall for Shaft Breach
Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.
Product
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1644-2025·2025-04-30
Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk
Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.
Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Category
Medical Device
Distribution
Distributed nationwide

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651–675 of 5027