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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3676–3700 of 39948

  • ModerateFDA (Devices)·Z-2071-2025·2025-07-09

    Change Healthcare Cardiology Hemo Software Unexpected Shutdown Risk

    Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.

    Product
    Change Healthcare Cardiology Hemo Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2025·2025-07-09

    BD Heyman Coude Tip Catheters Recalled Over French Size Labeling Error

    C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.

    Product
    BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2038-2025·2025-07-09

    VITROS 5600 Integrated System software anomaly reported

    Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2046-2025·2025-07-09

    Valeda light therapy devices shipped with European Union electrical configuration

    Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.

    Product
    Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2025·2025-07-02

    Omnipod 5 iOS App software design issue causes insulin overdose risk

    Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.

    Product
    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1958-2025·2025-07-02

    Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.

    Product
    Extended Tip Applicator, 8CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2025·2025-07-02

    Broselow Pediatric Emergency Rainbow Tape recalled for incorrect dosing values

    SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.

    Product
    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2023-2025·2025-07-02

    BD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall

    Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2025·2025-07-02

    Extended Tip Applicator 8CM medical devices recalled due to sterility concerns

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.

    Product
    Extended Tip Applicator 8CM, Box of 1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1959-2025·2025-07-02

    Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues

    Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.

    Product
    Extended Tip Applicator, 15 CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1961-2025·2025-07-02

    MicroMyst Applicator recalled due to lack of sterility assurance

    Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.

    Product
    MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2025·2025-07-02

    BD Insyte Autoguard Winged IV Catheter needle retraction failure recall

    Becton Dickinson is recalling BD Insyte Autoguard Winged IV Catheters (Ref. 381533, Lot 4282452) because the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1996-2025·2025-07-02

    DxI 9000 Access Immunoassay Analyzer calibration system error recall

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.

    Product
    DxI 9000 Access Immunoassay Analyzer C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2025·2025-07-02

    BD Insyte Autoguard BC Pro Winged Shielded IV Catheter Needle Retraction Issue

    Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (18 GA x 1.16 in, Lot 4208538) due to reports that the catheter needle may be slow to retract or fail to retract completely.

    Product
    REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2025·2025-07-02

    BD Pyxis Dispensing Cabinet Software Configuration Error Medical Device Recall

    CareFusion is recalling BD Pyxis automated dispensing cabinets and related devices due to a software configuration issue that can prevent user access to the medication dispensing application. This may delay patient care when Microsoft patches are installed during system upgrades.

    Product
    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2025·2025-07-02

    GE Healthcare Versana Ultrasound Systems display incorrect fetal weight data

    GE Healthcare Versana Premier R3 and LOGIQ F R3 ultrasound systems can display previous obstetric patient data in fetal weight measurement reports, potentially leading to incorrect clinical decisions based on inaccurate fetal size and growth calculations.

    Product
    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2008-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw labeling mismatch recall

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1999-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction failure recall

    Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction failure

    Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (20 GA x 1.16 in, REF 381434) because the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screws Package Labeling Mismatch

    Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2005-2025·2025-07-02

    BD Insyte Autoguard Shielded IV Catheter needle retraction malfunction

    Becton Dickinson is recalling a specific lot of BD Insyte Autoguard Shielded IV Catheters due to reports that the catheter needle may be slow to retract or fail to retract.

    Product
    REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2025·2025-07-02

    BD Insyte Autoguard Winged Shielded IV Catheter Needle Retraction Issue

    Becton Dickinson is recalling BD Insyte Autoguard Winged Shielded IV Catheters (Lot# 4282308) because the catheter needle may be slow to retract or fail to retract entirely following use.

    Product
    REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2025·2025-07-02

    REMISOL Advance Medical Device Software Defect Affecting Reference Range Calculations

    A software issue in REMISOL Advance may incorrectly process date-of-birth information from laboratory systems, causing incorrect reference range calculations and potentially auto-validating erroneous test result flags. The actual test results are not changed, but their evaluation may be affected.

    Product
    REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2025·2025-07-02

    Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error

    Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.

    Product
    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2025·2025-07-02

    Philips Spectral CT Computed Tomography X-ray System Software

    Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.

    Product
    Spectral CT. Computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    19 states