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 the agency’s own highest classification or reported deaths or serious injuries, 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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12426–12450 of 27470

  • HighFDA (Devices)·Z-0690-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 178 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    Five IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0661-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 86 IcePearl 2.1 CX Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 18,731 IceRod 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 CX 90¿ Cryoablation Needle¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2021·2020-12-30

    GA Health Recalls 10,000 STOPCON Suction Valves for GI Endoscopes

    GA Health Company Limited is recalling 10,000 STOPCON Suction Valves for GI endoscopes because the suction button is reported sticky or broken, which may cause prolonged procedures.

    Product
    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2021·2020-12-30

    PryTime Medical Recalls ER-Reboa Plus Catheters Due to Marking Errors

    PryTime Medical is recalling 3 units of ER-Reoba Plus Catheters because they may have incorrect balloon and arterial line markings, which could delay procedures or injure patients.

    Product
    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2021·2020-12-30

    CryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures

    CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.

    Product
    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 243 IceRod i-Thaw Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2021·2020-12-30

    Boston Scientific Recalls IceSeed Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 788 IceSeed 1.5 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceSeed" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2021·2020-12-30

    GA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect

    GA Health Company Limited is recalling 10,000 ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2021·2020-12-30

    ConMed Recalls Infinity ACL Tibial Tip Guides Due to Misalignment

    ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2021·2020-12-30

    ICU Medical Recalls ChemoLock Admin Sets Due to Molding Defect

    ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.

    Product
    30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 729 IceSphere 1.5 S 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 S 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0647-2021·2020-12-30

    GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects

    GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2021·2020-12-30

    GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects

    GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button is reported sticky or broken, which may cause prolonged procedures.

    Product
    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2021·2020-12-30

    GE Healthcare Recalls Two Revolution CT ES Units for Protocoling Error

    GE Healthcare is recalling two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 2,429 IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2021·2020-12-30

    Boston Scientific Recalls Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 262 IceRod 1.5 i-Thaw Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 i-Thaw" Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2021·2020-12-30

    B Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues

    B Braun Medical is recalling 248 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.

    Product
    APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide