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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12751–12775 of 13816

  • HighFDA (Devices)·Z-0136-2022·2021-10-27

    GE Discovery MR750 MRI System May Produce Incomplete Diagnostic Images

    GE Healthcare's Discovery MR750 3.0T MRI system may not capture all required image slices under certain conditions, resulting in gaps in diagnostic 3D images. Five devices are affected.

    Product
    Discovery MR750 3.0T nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0148-2022·2021-10-27

    CADD Administration Sets with Incorrect Air Filter Assembly

    Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.

    Product
    CADD Administration Sets, Model #21-7346-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0137-2022·2021-10-27

    GE SIGNA MRI Systems Software Issue Causes Missing Image Slices

    GE Healthcare's SIGNA Creator and SIGNA Explorer MRI systems may produce incomplete 3D images due to missing slices in software version DV29.1. Missing anatomical information could impact diagnostic accuracy.

    Product
    SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0141-2022·2021-10-27

    MRI System Recall: GE Healthcare SIGNA HDxt Missing Image Slices

    GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.

    Product
    1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0160-2022·2021-10-27

    Bone Screw Labeling Error: Actual Length May Not Match Package Label

    Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.

    Product
    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2022·2021-10-27

    Anti-Xa Assay On-Board Stability Reduced from 7 to 5 Days

    The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.

    Product
    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2022·2021-10-27

    Herniatome Surgical Device Recalled Due to Sterilization Failure

    ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.

    Product
    Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0135-2022·2021-10-27

    Discovery MR750w 3.0T MRI: Missing Image Slices in 3D Volume

    GE Healthcare recalls the Discovery MR750w 3.0T MRI system. Under certain software conditions, image slices may be missing, creating gaps in 3D diagnostic images.

    Product
    Discovery MR750w 3.0T nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0134-2022·2021-10-27

    GE SIGNA Pioneer MRI Recall for Missing Image Slices

    GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.

    Product
    SIGNA Pioneer nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0154-2022·2021-10-27

    Jamshidi Bone Marrow Biopsy Tray Recalled Due to Misbranding

    Bard Peripheral Vascular Inc. is recalling 360 Jamshidi Bone Marrow Biopsy Trays (Catalog # BEK3411, Lot # 0001378561) due to misbranded labeling. The FDA classified this as a Class II recall affecting healthcare facilities in 16 U.S. states and Puerto Rico.

    Product
    Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Inf
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0151-2022·2021-10-27

    HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2022·2021-10-27

    Heparin Activity Assay Labeling Correction: Reduced On-Board Stability

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2022·2021-10-27

    Plastic Tenaculum Surgical Instruments Recalled for Unconfirmed Manufacturing Standards

    Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.

    Product
    Tenaculum, Plastic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2022·2021-10-27

    Diagnostic Control Material Outside Expected Range, Potential for Delayed Results

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.

    Product
    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2022·2021-10-27

    Smith & Nephew cannulated screw label incorrectly indicates threading type

    Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.

    Product
    6.5MMX165MM CANNULATED SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0008-2022·2021-10-20

    Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0088-2022·2021-10-20

    Eco-Med Ultrasound Gel Recalled for Bacterial Contamination Risk

    Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.

    Product
    EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0090-2022·2021-10-20

    FDA Recalls Ultrasound Gel for Possible Bacterial Contamination

    Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.

    Product
    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0068-2022·2021-10-20

    Ultrasound gel products recalled for potential bacterial contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.

    Product
    ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2022·2021-10-20

    Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results

    Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2022·2021-10-20

    Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives

    Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2022·2021-10-20

    Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results

    Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide