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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12726–12750 of 13816

  • HighFDA (Devices)·Z-0133-2022·2021-10-27

    MRI System Software Defect May Cause Missing Anatomical Image Data

    GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.

    Product
    SIGNA Architect nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0121-2022·2021-10-27

    FDA Recalls P2131 Automated Field Steam Sterilizer for Electrical Grounding Defect

    Fort Defiance Industries is recalling the P2131 Automated Field Steam Sterilizer because the rear heater assembly lacks sufficient electrical grounding, creating a shock hazard. The recall affects 380 devices distributed nationwide and to Canada.

    Product
    P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2022·2021-10-27

    Canon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures

    Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.

    Product
    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2022·2021-10-27

    Philips EPIQ CVxi Ultrasound Systems Software Issue Causes System Unresponsiveness

    Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.

    Product
    EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
    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-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-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-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-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-0146-2022·2021-10-27

    Herniatome Surgical Instrument Recalled Due to Sterilization Process Failure

    ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.

    Product
    Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
    Category
    Medical Device
    Distribution
    2 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-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-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-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-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-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-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
  • 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-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-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-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