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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9851–9875 of 27470

  • HighFDA (Devices)·Z-1229-2022·2022-06-15

    Medical imaging software may display inaccurate measurement values

    GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

    Product
    Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1010-2022·2022-06-15

    Epidural Nerve Block Tray Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.

    Product
    Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2022·2022-06-15

    Tornado Embolization Microcoils recalled for unintended cannula in loading cartridges

    Cook Incorporated is recalling certain Tornado Embolization Microcoils due to unintended stainless-steel cannulas in loading cartridges. The foreign objects may affect device function.

    Product
    Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2022·2022-06-15

    Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula

    Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.

    Product
    Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2022·2022-06-15

    MedMinder Medication Dispenser Emergency Alert Function No Longer Operational

    MedMinder Medication Dispensers will no longer connect to the emergency alert system for all models. The device's emergency communication capability has been discontinued for approximately 2,701 units nationwide.

    Product
    MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1030-2022·2022-06-15

    Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.

    Product
    Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2022·2022-06-15

    FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination

    Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.

    Product
    V8 Immunodisplacement Kit REF 1803
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1138-2022·2022-06-08

    In-Line Ventilator Adaptor Recall: Risk of Reduced Oxygenation or Barotrauma

    Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.

    Product
    In-Line ventilator adaptor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2022·2022-06-08

    Hip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot

    MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.

    Product
    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2022·2022-06-08

    Medtronic cardiac catheter system recalled due to sterility barrier defect

    Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.

    Product
    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2022·2022-06-08

    FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.

    Product
    CVC Dressing Change Kit Catalog Number: 2491R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2022·2022-06-08

    Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements

    Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.

    Product
    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2022·2022-06-08

    Single Shot Epidural Tray recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.

    Product
    Single Shot Epidural Tray Catalog Number: 6797R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2022·2022-06-08

    Sterile Epidural Tray Recalled Due to Validation Uncertainty

    Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.

    Product
    Sterile Epidural Tray Catalog Number: 6259R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2022·2022-06-08

    Surgical Instrument Seal Defect Recall: da Vinci Energy SynchroSeal

    Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.

    Product
    DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2022·2022-06-08

    Baxter Peritoneal Dialysis Manifold Sets Recalled for Lack of FDA Clearance

    Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.

    Product
    5 Prong Manifold Set (with Luer Connectors)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2022·2022-06-08

    Epidural Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.

    Product
    Single Shot Epidural Tray Catalog Number: 6183R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2022·2022-06-08

    Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance

    Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.

    Product
    3,65 m Extension Set with Luer-lock Connector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide