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.

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2701–2725 of 27346

  • HighFDA (Devices)·Z-1736-2025·2025-05-14

    Introducer Needle REF NDL-107-04 Sterile Packaging Recall

    Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.

    Product
    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2025·2025-05-14

    Introducer Kit-Tearaway MicroSlide Medical Device Recall

    Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.

    Product
    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2025·2025-05-14

    GALT Centeze Catheter recalled due to potential sterile packaging seal failure

    Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.

    Product
    GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2025·2025-05-14

    Artix MT Thrombectomy Device recalled for incorrect vessel range specification

    Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.

    Product
    Artix MT Thrombectomy Device, REF: 32-102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2025·2025-05-14

    Atalante X Powered Exoskeleton Lateral Balance Loss Recall

    WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton due to a potential loss of lateral balance that could cause patients to fall. Three units have been distributed to rehabilitation facilities in Pennsylvania and New York.

    Product
    Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1735-2025·2025-05-14

    Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue

    Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.

    Product
    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2025·2025-05-14

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall

    Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
    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-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-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-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-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-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-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-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-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-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-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-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-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-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