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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2476–2500 of 27346

  • HighFDA (Devices)·Z-2098-2025·2025-07-16

    Nuclear medicine systems may show unintended radial detector motion during scans

    Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.

    Product
    Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2048-2025·2025-07-09

    Philips Ultrasound Transducers Recalled After Over-Refurbishment

    Philips Ultrasound, Inc is recalling 5,230 Philips 3D9-3v Transducer devices because they were refurbished beyond their useful life, posing a risk of device failure during medical use.

    Product
    Philips 3D9-3v Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2025·2025-07-09

    BiPAP V30 Auto ventilators are not indicated for respiratory failure

    The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.

    Product
    BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2036-2025·2025-07-09

    BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips

    Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.

    Product
    BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2041-2025·2025-07-09

    HardyCHROM CRE Culture Medium Recalled for Quality Control Failure

    Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.

    Product
    HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Devices)·Z-2013-2025·2025-07-09

    Servo-u ventilators may measure patient circuit compliance inaccurately

    The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.

    Product
    Servo-u Ventilator System. Model Number: 6688600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2037-2025·2025-07-09

    BiPAP A40 ventilators are not indicated for respiratory failure patients

    The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.

    Product
    BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2015-2025·2025-07-09

    Servo-u MR Ventilator System inaccurate patient circuit compliance measurement

    Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.

    Product
    Servo-u MR Ventilator System. Model Number: 6888800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2014-2025·2025-07-09

    Servo-n ventilators may measure patient circuit compliance inaccurately

    The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.

    Product
    Servo-n Ventilator System. Model Number: 6694800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2025·2025-07-09

    Apex Knee System components recalled over loss of sterile packaging integrity

    Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.

    Product
    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2025·2025-07-09

    Medline retinal packs recalled because catheter needle may fail to retract

    Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2025·2025-07-09

    VITROS 4600 chemistry systems may report results using expired diluent packs

    VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.

    Product
    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2025·2025-07-09

    BD Heyman Follower Straight Tip catheters with incorrect French size packaging

    C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.

    Product
    BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2044-2025·2025-07-09

    Medline IV Catheter Kits Recalled Over Needle Retraction Issue

    Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2025·2025-07-09

    Cardiology hemodynamics software update may cause unexpected system shutdowns

    Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.

    Product
    Change Healthcare Cardiology Hemodynamics Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2025·2025-07-09

    BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors

    Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.

    Product
    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-2058-2025·2025-07-09

    Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips S5-1 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2025·2025-07-09

    ADVIA Hematology System Control Product Recall for Platelet Value Error

    Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2025·2025-07-09

    Medline IV Catheters Recalled for Needle Retraction Failure

    Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2025·2025-07-09

    Bard Urologist's Tray Recalled Over Incorrect French Size Labeling

    C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.

    Product
    REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2025·2025-07-09

    Philips C9-5EC Ultrasound Transducer Devices Recalled

    Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips C9-5EC Transducer.
    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-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