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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10476–10500 of 27470

  • 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-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-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2022·2022-01-05

    VIDAS Lyme diagnostic test device recalled due to substrate error

    bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

    Product
    VIDAS Lyme IgG II (LYM), REF 417401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2022·2022-01-05

    VIDAS Measles IgG Test Kit Recalled Due to Substrate Error

    bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS Measles IgG (MSG), REF 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2022·2022-01-05

    VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

    bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

    Product
    VIDAS Mumps IgG (MPG), REF 30218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2022·2022-01-05

    Karl Storz Endoscope Sterilization Trays Instructions for Use Updated

    Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.

    Product
    Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELES
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0421-2022·2022-01-05

    FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation

    Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.

    Product
    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
    Category
    Medical Device
    Distribution
    1 state
  • 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-0444-2022·2022-01-05

    Catalys Precision Laser System recalled for remote code execution vulnerability

    AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.

    Product
    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0435-2022·2022-01-05

    VIDAS Estradiol II Test Device Recalled Due to Substrate Error

    bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.

    Product
    VIDAS Estradiol II, REF 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2022·2022-01-05

    VIDAS procalcitonin diagnostic test substrate error causes testing delays

    Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.

    Product
    VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0394-2022·2021-12-29

    WIRION Embolic Protection System Filter Withdrawal Difficulties

    Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.

    Product
    WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0383-2022·2021-12-29

    Stealthstation and Synergy Cranial surgical navigation system software synchronization error

    Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.

    Product
    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator sensors because they may fail to tighten properly onto surgical instruments. This functional defect could affect safe use during medical procedures.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2022·2021-12-29

    Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results

    Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.

    Product
    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2022·2021-12-29

    Stryker DARCO Screw Recall: Incorrect Product in Packaging

    Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.

    Product
    Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0417-2022·2021-12-29

    Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy

    A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.

    Product
    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0403-2022·2021-12-29

    Hemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall

    Maquet Cardiovascular is recalling Hemashield Gold vascular grafts due to probable mislabeling. A different graft product may have been packaged in the carton.

    Product
    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2022·2021-12-29

    Leica M220 F12 Surgical Microscope Optics Carrier May Drop Into Surgical Field

    Leica Microsystems is recalling 2,800 M220 F12 surgical microscopes because the optics carrier may unintentionally drop into the surgical field, risking patient contact. No injuries have been reported.

    Product
    Leica Microsystems M220 F12 Microscope Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2022·2021-12-29

    Nurse Call Communication System Components May Fail to Reboot

    Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.

    Product
    These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2022·2021-12-29

    Newborn Kit Needles Recalled Due to Sterility Defect

    ROi CPS LLC is recalling regard Clinical Packaging Solutions Newborn Kits (Item 830096005) containing non-sterile needles. The kits were distributed to Missouri.

    Product
    regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
    Category
    Medical Device
    Distribution
    1 state