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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11976–12000 of 40112

  • HighFDA (Devices)·Z-1676-2022·2022-09-14

    Laboratory diagnostic system may report inaccurate results during shutdown

    The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.

    Product
    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2022·2022-09-14

    VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results

    The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.

    Product
    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2022·2022-09-14

    Surgical instrument convenience packs recalled for inadequate sterilization validation

    American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1691-2022·2022-09-14

    Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation

    American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.

    Product
    Various Pacemaker Packs, Cardio Thoracic Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1680-2022·2022-09-14

    Medical embolization coil system recalled for untested alternate supplier material

    BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.

    Product
    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1690-2022·2022-09-14

    Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various Angiography/Cath Lab packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1698-2022·2022-09-14

    Medical device convenience packs exposed to unvalidated sterilization cycles

    American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1683-2022·2022-09-14

    Medline Chest Tube Kit Recalled for Non-Sterile Tape Component

    Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.

    Product
    Medline CHEST TUBE REORDER NO: DYNJ36762A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2022·2022-09-14

    Cysto Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.

    Product
    Various Cysto Packs
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1520-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2022·2022-09-07

    Medtronic endotracheal tubes recalled for reported airway obstruction risk

    Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.

    Product
    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1521-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2022·2022-09-07

    Metalogix Self-Drill Half-Pin Surgical Component Recalled for Tip Breakage

    New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.

    Product
    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1660-2022·2022-09-07

    ARCHITECT STAT Troponin-I Reagent Kit Recalled for Insufficient Blocking Agents

    Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.

    Product
    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2022·2022-09-07

    Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure

    Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.

    Product
    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2022·2022-09-07

    Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.

    Product
    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2022·2022-09-07

    Eye imaging device software defect affects surgical planning calculations

    Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.

    Product
    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1670-2022·2022-09-07

    ZOOM LATITUDE Programmer Recalled for Potential Software Communication Anomalies

    Boston Scientific recalled the ZOOM LATITUDE Programmer (Model 2868) for potential software anomalies affecting communication with certain transvenous defibrillators. No injuries have been reported. The recall involves 17,172 units distributed worldwide.

    Product
    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1666-2022·2022-09-07

    Radiographic imaging system may exceed radiation dose limits in biplane mode

    Canon Medical's Alphenix i imaging systems may deliver radiation dose rates exceeding acceptable limits during biplane fluoroscopic procedures. Sixteen systems nationwide with software versions 8.0, 9.0, or 9.2 and TFP 1200C detector are affected.

    Product
    INFX-8000V. For radiographic and fluoroscopic studies and intervention.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2022·2022-09-07

    Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

    Boston Scientific is recalling ZOOM LATITUDE programmers due to potential software anomalies that could affect communication with implantable defibrillators. No injuries have been reported.

    Product
    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1671-2022·2022-09-07

    Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

    Boston Scientific ZOOM LATITUDE programmer software may have anomalies when communicating with certain Boston Scientific defibrillators, potentially affecting device programming and communication functions.

    Product
    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2022·2022-09-07

    RT-PCR Kit Recalled Due to False Positive Test Results

    Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.

    Product
    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1645-2022·2022-09-07

    X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall

    Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.

    Product
    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2022·2022-09-07

    therascreen FGFR RGQ Kit Recalled for Increased False Positive Results

    Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.

    Product
    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
    Category
    Medical Device
    Distribution
    4 states