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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10701–10725 of 27470

  • HighFDA (Devices)·Z-0001-2022·2021-11-03

    RAPTAR Laser Range Finders Recalled for Field Modification Safety Risk

    Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.

    Product
    RAPTAR Laser Range Finders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Label

    W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0176-2022·2021-11-03

    ASC PneumoLiner surgical device recalled due to manufacturing orientation defect

    Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.

    Product
    ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, cons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2022·2021-11-03

    Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters

    Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.

    Product
    Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0107-2022·2021-10-27

    Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician

    Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.

    Product
    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0091-2022·2021-10-27

    Cardiosave Li-Ion battery pack recalled for insufficient runtime specification

    Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.

    Product
    Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
    19 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
  • 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-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
    19 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
    19 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-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-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
    19 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-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-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
    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
    19 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
    19 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-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-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-0158-2022·2021-10-27

    Medtronic surgical blades recalled for tip breaks and vibration

    Medtronic recalls 274,991 sterile surgical blades due to complaints of tip breaks and vibration during use. The blades are components of surgical systems used in brain and ENT procedures.

    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 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (
    Category
    Medical Device
    Distribution
    Distributed nationwide