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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

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4301–4325 of 13526

  • HighFDA (Devices)·Z-0680-2025·2024-12-25

    Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk

    Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.

    Product
    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-1
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0686-2025·2024-12-25

    Philips Access Point Software Issue Risks Patient Data Loss

    Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.

    Product
    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2025·2024-12-25

    Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction

    Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.

    Product
    mint Lesion, Software Versions: 3.9.0 through 3.9.5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2025·2024-12-25

    Hillrom Temperature Management Controller Power-On Self-Test Error Code Update

    Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.

    Product
    Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0693-2025·2024-12-25

    Bronchoscopic system may lose power due to defective component

    A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.

    Product
    Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0685-2025·2024-12-25

    ECG Patch Recorder Serial Number Mismatch - Eclipse Mini

    Spacelabs Healthcare is recalling the Eclipse Mini ECG patch recorder because incorrect serial numbers may be programmed into devices, causing a mismatch between the physical label and internal serial number.

    Product
    Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0684-2025·2024-12-25

    Eclipse PRO Holter Recorders Recalled for Serial Number Mismatch

    Spacelabs Healthcare recalls 13,202 Eclipse PRO Holter recorders due to manufacturing error where the programmed serial number may not match the physical label. Affected devices were manufactured between April 2021 and November 2024.

    Product
    Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0700-2025·2024-12-25

    HOT DOG Temperature Management Controller Instructions for Use Update

    Augustine Temperature Management is updating instructions for HOT DOG Patient Warming Controllers (Models WC71, WC71R) regarding a power-on self-test error code. The update affects 135 units distributed in the US and Canada.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0699-2025·2024-12-25

    Femoral Knee Prosthesis Components May Have Incorrect Packaging

    MicroPort Orthopedics recalls EVOLUTION MP femoral knee prosthesis components due to incorrect packaging. The devices are correctly marked internally but may have wrong labels on their packaging.

    Product
    EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0701-2025·2024-12-25

    Augustine HOT DOG Temperature Management Controller Instructions Update

    Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0691-2025·2024-12-25

    K-Systems R65 embryo incubator temperature may exceed setpoint

    CooperSurgical's K-Systems R65 Trolley reproductive incubators may experience temperature excursions above desired setpoints, though devices will alarm when this occurs. The FDA issued a Class II recall of 43 units across eight U.S. states.

    Product
    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and em
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0671-2025·2024-12-18

    Automated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors

    The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.

    Product
    BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2025·2024-12-18

    MICRO-X Rover Mobile X-ray System Exposure Timing Defect Recalled

    Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2025·2024-12-18

    MICRO-X Rover Mobile X-ray System delivers lower-than-set radiation doses

    Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2025·2024-12-18

    ReNew Microscissor Tip Disposable Recalled Due to Heat Shrink Failure

    Microline Surgical is recalling ReNew Microscissor Tip (Disposable) lot 00172110 due to a 2% failure rate where the heat shrink breaks off.

    Product
    Microscissor Tip (Disposable); Microline Catalog #: 3122.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2025·2024-12-18

    Galaxy Bronchoscope Biopsy Tool Insertion Risk at Sharp Bend Angles

    Noah Medical is recalling Galaxy bronchoscope units due to risk that biopsy tools may require excessive force or fail to pass through the scope channel when the bronchoscope is sharply bent, potentially causing tissue injury or pneumothorax.

    Product
    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2025·2024-12-18

    Medical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results

    Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.

    Product
    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0674-2025·2024-12-18

    Convertor Isolation Gowns may fail protective barrier requirements

    Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.

    Product
    Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2025·2024-12-18

    MICRO-X Rover Medical X-ray System Hand Switch Activation Issue

    Micro-X Ltd. is recalling 23 MICRO-X Rover Mobile X-ray Systems because the hand switch may be accidentally activated when dropped, causing the system to become unresponsive during patient imaging.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2025·2024-12-18

    FDA Recalls DKS Disposable Kerrison System Surgical Instruments

    Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.

    Product
    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Sma
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0670-2025·2024-12-18

    BD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect

    An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.

    Product
    BD Pyxis MedStation ES, REF: 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2025·2024-12-18

    Cardinal Health isolation gowns recalled for failing hydrostatic pressure standards

    Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.

    Product
    Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2025·2024-12-18

    DiaSorin LIAISON Device Recall: Loose Caps May Cause Incorrect Patient Test Results

    DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.

    Product
    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0678-2025·2024-12-18

    Hermes Medical Imaging Software May Cause Incorrect Image Reconstruction

    Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.

    Product
    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
    Category
    Medical Device
    Distribution
    15 states