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 13837

  • HighFDA (Devices)·Z-0139-2022·2021-10-27

    GE SIGNA Artist MRI System May Produce Incomplete Image Scans

    GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.

    Product
    SIGNA Artist nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0155-2022·2021-10-27

    medfusion Stopcock devices recalled due to sterility assurance deficiency

    Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.

    Product
    medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-10
    Category
    Medical Device
    Distribution
    0 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-0138-2022·2021-10-27

    GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices

    GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.

    Product
    SIGNA Voyager nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0161-2022·2021-10-27

    Easi-Care Gait Belt Metal Buckle may fail at lower loads than rated

    Kinsman Enterprises is recalling approximately 13,123 Easi-Care Gait Belts because the metal buckle may fail at loads below the labeled 600-pound capacity, creating a fall risk for users.

    Product
    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0131-2022·2021-10-27

    IUD Insertion Kit Recalled Over Manufacturing Standards Verification Issues

    Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.

    Product
    Standard IUD Insertion Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2022·2021-10-27

    Medtronic Sterile Surgical Blades Recalled for Tip Breaks and Vibration

    Medtronic Xomed, Inc. is recalling 274,991 sterile single-use surgical blades used in ENT surgical procedures due to increased complaints of tip breaks and vibration during use.

    Product
    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2022·2021-10-27

    MRI System Software Defect Causes Missing Image Slices

    GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.

    Product
    SIGNA Premier nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0140-2022·2021-10-27

    MRI system software may produce incomplete 3D images

    GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.

    Product
    Optima MR450w 1.5T nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0147-2022·2021-10-27

    Central Line Dressing Kit Component Has Shorter Expiration Than Kit Label

    Medical Action Industries recalls Central Line Dressing Change kits because the ChloraPrep 3ml component expires sooner than the kit label indicates. Users should discontinue use and contact their supplier.

    Product
    Kit: Central Line Dres Change 20/Cs
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0153-2022·2021-10-27

    Jamshidi Bone Marrow Biopsy Tray Recalled for Misbranding

    Bard Peripheral Vascular Inc is recalling an Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray due to misbranding. A total of 360 devices were distributed to healthcare facilities across multiple U.S. states.

    Product
    Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. O
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0122-2022·2021-10-27

    MPR Slotted Mallet recalled for potential head separation

    Implant Resource Inc is recalling the MPR Slotted Mallet (Model MPR-1120-1000, Lot 200911-1-1) due to potential separation of the mallet head from the handle and unexpected deformations on the striking surface.

    Product
    MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0162-2022·2021-10-27

    COVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials

    DiaSorin Molecular is recalling the SIMPLEXA COVID-19 Positive Control Pack due to unapproved raw materials in manufacturing that may cause delayed amplification signals during testing.

    Product
    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2022·2021-10-27

    Smiths Medical Portex Loss of Resistance Device Lacks Sterilization and Reuse Labeling

    Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device because product labeling lacks information on sterilization procedures and does not prohibit reuse. The recall affects 3,420 devices distributed internationally.

    Product
    smiths medical portex Loss of Resistance Device, REF 100/398/000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0157-2022·2021-10-27

    Medtronic Surgical Blades Recalled Due to Tip Breaks and Vibration

    Medtronic is recalling surgical blades used in ENT procedures due to increasing complaints of tip breaks and vibration. Approximately 274,991 devices distributed worldwide are affected.

    Product
    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0145-2022·2021-10-27

    Herniatome lumbar surgical instrument recalled for sterilization failure

    ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.

    Product
    Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
    Category
    Medical Device
    Distribution
    2 states
  • 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-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-0159-2022·2021-10-27

    Orthopedic Bone Screws Recalled Due to Potential Length Mislabeling

    Limacorporate S.p.A is recalling 151 units of bone screws because the labeled length may not match the actual screw length included in the package.

    Product
    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
    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-0124-2022·2021-10-27

    Atellica IM 1300 Analyzer Reagent Overflow at High Altitudes

    Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.

    Product
    Atellica IM 1300 Analyzer, SMN 11066001
    Category
    Medical Device
    Distribution
    23 states