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 39987

  • ModerateFDA (Devices)·Z-2086-2025·2025-07-09

    ADVIA hematology calibrator lots carry incorrect platelet value assignments

    ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.

    Product
    ADVIA¿ 120/2120/2120i SETpoint Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2025·2025-07-09

    VITROS opiate reagent lots may give low quality control results

    VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.

    Product
    VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2025·2025-07-09

    My3D Personalized Solutions Humeral Cup lacks required inspections

    Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.

    Product
    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2025·2025-07-09

    Philips eL18-4 Ultrasound Transducers Recalled for Defective Refurbishment

    Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.

    Product
    Philips eL18-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2025·2025-07-09

    ARTIS angiography systems may incorrectly report a high radiation dose

    ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2059-2025·2025-07-09

    Philips S7-2 Transducer Ultrasound Devices Recalled for Refurbishment

    Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices that were refurbished beyond their useful life. The affected devices have been distributed domestically and internationally.

    Product
    Philips S7-2 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2025·2025-07-09

    BD FACS setup beads have errors in spectral overlap factors table

    BD FACS 7-Color Setup Beads are being recalled because errors in the spectral overlap factors table may affect accurate setup of the flow cytometry instrument. 590 units affected.

    Product
    REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • 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-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-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-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
  • 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-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-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-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
  • 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