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 the agency’s own highest classification or reported deaths or serious injuries, 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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13476–13500 of 40112

  • ModerateFDA (Devices)·Z-0172-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0163-2022·2021-11-03

    Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number

    Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.

    Product
    Pneupac paraPac plus 300 ventilator kit, REF P300NGB
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0168-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date

    W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.

    Product
    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0166-2022·2021-11-03

    GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date

    W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0167-2022·2021-11-03

    GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling

    GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.

    Product
    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • 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…
    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.…
    Category
    Medical Device
    Distribution
    1 state
  • 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
    1 state
  • 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-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
    19 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-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.…
    Category
    Medical Device
    Distribution
    16 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…
    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.…
    Category
    Medical Device
    Distribution
    0 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-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
    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-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-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-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-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