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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4301–4325 of 13543

HighFDA (Devices)·Z-0692-2025·2024-12-25
K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting
CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.
Product
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown 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.,
Category
Medical Device
Distribution
14 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-0688-2025·2024-12-25
K-Systems G85 Mini Incubator May Exceed Desired Temperature
CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.
Product
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 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
Category
Medical Device
Distribution
14 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-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
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
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
HighFDA (Devices)·Z-0676-2025·2024-12-18
Philips Allura Xper X-ray Systems Prone to Clamping Bolt Failure and Collision Risk
Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.
Product
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper
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-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-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-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-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-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-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-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-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-0672-2025·2024-12-18
BD Pyxis medication dispensing cabinet software issue risks wrong medication access
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
Product
BD Pyxis CII Safe ES, REF: 1116-00
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
ModerateFDA (Devices)·Z-0669-2025·2024-12-18
Hologic Sizer Set Missing Instructions for Use and Sterilization
Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Category
Medical Device
Distribution
Distributed nationwide

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4301–4325 of 13543