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

3601–3625 of 27346

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-0695-2025·2024-12-25
HUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
Product
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0689-2025·2024-12-25
K-Systems T47 Warming Plate may exceed desired temperatures
The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.
Product
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 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
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
HighFDA (Devices)·Z-0696-2025·2024-12-25
ET Tube Holder Recalled for Risk of Facial Skin Injury
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
Product
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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-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-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-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-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0608-2025·2024-12-11
GE Healthcare CT Systems Recalled Due to Progressive Image Rotation
GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.
Product
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0606-2025·2024-12-11
CT imaging system issue causes progressive image rotation during scans
GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.
Product
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0598-2025·2024-12-11
Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates
Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.
Product
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0615-2025·2024-12-11
GE Healthcare CT Operator Console Update: Images May Rotate Progressively
GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.
Product
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Category
Medical Device
Distribution
0 states

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3601–3625 of 27346