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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10476–10500 of 27441

  • HighFDA (Devices)·Z-0489-2022·2022-01-19

    Hip Stem Device Recalled Due to Undersized Bore Diameter Risk

    DePuy Orthopaedics recalls the GLOBAL UNITE STD STEM SZ 14 hip stem in 451 units worldwide due to undersized spigot bore diameter. The defect may prevent proper separation of the stem during surgery without surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2022·2022-01-19

    RefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy

    Reflexion Medical is recalling three RefleXion X1 radiotherapy systems due to a potential dose discrepancy when delivering treatment in Feet First Supine patient orientation.

    Product
    RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2022·2022-01-19

    Philips Azurion X-ray System recalled for startup and emergency stop failures

    Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2022·2022-01-12

    COVID-19 Diagnostic Kit Recall for Inaccurate Test Results

    Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0445-2022·2022-01-12

    Power wheelchairs with LiNX Gyro module recalled for deceleration control failure

    Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.

    Product
    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2022·2022-01-12

    Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination

    DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.

    Product
    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0462-2022·2022-01-12

    Alinity m System recalled for software defect in amplification detection

    Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0463-2022·2022-01-12

    Abbott Alinity m System camera firmware installation issue

    Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0453-2022·2022-01-12

    Medshape DYNANAIL MINI surgical nail recalled for improper endcap length

    Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.

    Product
    DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0461-2022·2022-01-12

    Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures

    Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2022·2022-01-12

    Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results

    Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.

    Product
    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2022·2022-01-12

    Invacare AVIVA FX power wheelchair LiNX Gyro deceleration malfunction

    Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.

    Product
    Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2022·2022-01-12

    UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants

    Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.

    Product
    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2022·2022-01-12

    Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery

    Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.

    Product
    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2022·2022-01-12

    Surgical Instrument Tray Recalled for Incorrect Keel Punch Component

    Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.

    Product
    Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2022·2022-01-12

    Medtronic Abre Venous Stent System recalled for reports of stent migration

    Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.

    Product
    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2022·2022-01-12

    Hemodialysis Delivery System distributed without FDA premarket approval

    The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.

    Product
    DBB-06 Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2022·2022-01-12

    Invacare AVIVA Storm RX Power Wheelchairs Recalled for Firmware Deceleration Malfunction

    Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.

    Product
    Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2022·2022-01-05

    Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion

    The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.

    Product
    Model B35200 - Percept PC BrainSense Implantable Neurostimulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2022·2022-01-05

    Cancer treatment linear accelerator systems recalled for wrong-site dosing risk

    Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.

    Product
    ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2022·2022-01-05

    Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias

    Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.

    Product
    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2022·2022-01-05

    VIDAS Clostridium Difficile GDH test substrate error causes test failure

    bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.

    Product
    VIDAS Clostridium Difficile GDH, REF 30125-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2022·2022-01-05

    Medical Device Aberrometer Systems Affected by Remote Code Execution Vulnerability

    AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.

    Product
    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0419-2022·2022-01-05

    da Vinci SP Surgical System Software Energy Delivery Defect

    Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.

    Product
    da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4…
    Category
    Medical Device
    Distribution
    Distributed nationwide