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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8976–9000 of 27393

  • HighFDA (Devices)·Z-0413-2023·2022-12-14

    Bipolar Forceps Recall: Incomplete Instructions for Surgical Device

    BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.

    Product
    CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2023·2022-12-14

    Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2023·2022-12-14

    Spinal pedicle screws recalled for potential intraoperative screw head separation

    Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.

    Product
    LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0401-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Use and Maintenance Instructions

    CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2023·2022-12-14

    LineSider Spinal System Screws Recalled for Potential Weld Separation

    Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2023·2022-12-14

    Getinge Flow-c and Flow-e Anesthesia Systems: Backup Battery Failure Risk

    Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.

    Product
    Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2023·2022-12-14

    Bipolar Surgical Forceps Recalled Due to Missing Instructions for Use

    CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2023·2022-12-14

    Propel Mini Sinus Implant Recalled for Incorrect Product Label Information

    Intersect ENT is recalling 611 units of Propel Mini Mometasone Furoate Sinus Implant due to incorrect product identification information on the label. The label displays wrong reference numbers and UDI-DI codes.

    Product
    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2023·2022-12-14

    Omnipod 5 Controller charging port melting poses minor burn risk

    Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.

    Product
    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

    Carefusion is recalling 418 units of bipolar surgical forceps because the provided instructions lack critical content about power supply interface and maintenance. Complete manufacturer instructions are necessary for safe device operation.

    Product
    CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2023·2022-12-14

    Bipolar Forceps Recall Due to Incomplete Instructions for Use

    BD is recalling CareFusion bipolar forceps due to incomplete Instructions for Use. The IFU is missing critical information about power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2023·2022-12-14

    Bipolar Forceps Recall Due to Incomplete Instructions for Use

    BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.

    Product
    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2023·2022-12-14

    Philips Ingenia Elition X MR System Gradient Coil Fire and Smoke Hazard

    Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.

    Product
    Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.

    Product
    CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2023·2022-12-14

    Treadmill safety mechanism may fail to stop during fall

    Full Vision Inc. Trackmaster treadmills (Model #317-07926GE) may fail to stop during a fall if the magnetic safety mechanism malfunctions. 69 units are affected.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0393-2023·2022-12-14

    Bipolar forceps recall for incomplete operating and maintenance instructions

    Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical information about power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2023·2022-12-14

    Philips MR 7700 System Upgrade Recalled Due to Gradient Coil Fire Risk

    Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.

    Product
    Philips Upgrade to MR 7700 System, Model Number 782130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2023·2022-12-07

    CMV IgM EIA Diagnostic Test Recalled for Increased False Positives

    Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.

    Product
    CMV IgM EIA, in vitro diagnostic.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0345-2023·2022-12-07

    Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification

    Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.

    Product
    Accelerate PhenoTest BC kit REF 10101018
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0354-2023·2022-12-07

    Alcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries

    Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.

    Product
    Alcon Custom Pak Surgical Procedure Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2023·2022-12-07

    Intuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure

    Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.

    Product
    INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0324-2023·2022-12-07

    CoViPoint COVID Test Kits Distributed Without FDA Approval or Clearance

    GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.

    Product
    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0343-2023·2022-12-07

    Surgical Gown Recall Due to Potential Open Seal Pouches Affecting Sterility

    Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.

    Product
    Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0344-2023·2022-12-07

    Mobile CT Scanner Battery Fire Risk in Units With Bypassed Monitoring

    Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.

    Product
    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0347-2023·2022-12-07

    Medical laboratory reagent recalled for potential false-negative test results

    Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.

    Product
    GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
    Category
    Medical Device
    Distribution
    11 states