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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3651–3675 of 13543

  • HighFDA (Devices)·Z-1362-2025·2025-03-26

    Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance

    American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.

    Product
    VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2025·2025-03-26

    Beckman Coulter DxI 9000 Analyzer Communication Failure Recall

    Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2025·2025-03-26

    Hip Prosthetic Stem Recalled for Incorrect Product Code Label

    A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2025·2025-03-26

    Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues

    Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.

    Product
    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2025·2025-03-26

    Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier

    37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2025·2025-03-26

    IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling

    Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.

    Product
    IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2025·2025-03-26

    Access 2 Immunoassay Analyzer motor alignment issue may delay results

    Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.

    Product
    Access 2 Immunoassay Analyzer, Catalog Number 81600N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2025·2025-03-26

    Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling

    Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1289-2025·2025-03-19

    Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter

    Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.

    Product
    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1306-2025·2025-03-19

    Aortic Root Cannula Recall for Loose Male Luer Component

    Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.

    Product
    Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1304-2025·2025-03-19

    BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue

    BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.

    Product
    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1305-2025·2025-03-19

    BD Care Coordination Engine Software May Send Outdated Programming Requests

    BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.

    Product
    BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1327-2025·2025-03-19

    Blood Pump Recalled for Potential Fluid Leakage During Clinical Use

    Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.

    Product
    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure

    ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1320-2025·2025-03-19

    ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity

    ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2025·2025-03-19

    COR Disposable Cartilage Transplant Kit recalled for missing graft loader pin

    DePuy Mitek's COR Disposable Cartilage Transplant System is being recalled because some units are missing a pin in the graft loader component, which could affect surgical function.

    Product
    COR Disposable Kit, 8 mm. Cartilage Transplant System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2025·2025-03-19

    Hemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use

    Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2025·2025-03-19

    GE Healthcare CT Systems May Leak Coolant Fluid on Floor

    GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.

    Product
    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1300-2025·2025-03-19

    GE Healthcare Revolution CT systems coolant leak creates slipping hazard

    Certain GE Healthcare Revolution CT and Apex series systems may leak coolant fluid near the gantry base, creating a potential slip-fall hazard if left unnoticed.

    Product
    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1319-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2025·2025-03-19

    ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk

    ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2025·2025-03-19

    Stryker CinchLock anchor recalled due to pullwire breakage

    Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.

    Product
    Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2025·2025-03-19

    Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2025·2025-03-19

    GE Healthcare Revolution CT Systems: Coolant Fluid Leak Creates Slip Hazard

    GE Healthcare Revolution Apex and Revolution CT series systems may leak coolant fluid onto the floor near the gantry. The blue-colored, non-toxic fluid poses a slip and fall hazard if not noticed.

    Product
    GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states