The Recall Desk

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.

Filters

Agency

Category

Minimum severity

Clear filters

4001–4025 of 39948

  • 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2025·2025-05-07

    epoc BGEM BUN Test Cards for Blood Analysis System Recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2025·2025-05-07

    Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

    Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

    Product
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2025·2025-05-07

    Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

    Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

    Product
    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2025·2025-05-07

    Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles

    Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2025·2025-05-07

    Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector

    Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.

    Product
    3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the
    Category
    Medical Device
    Distribution
    Distributed nationwide