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.
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.
Minimum severity
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.
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.
Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.
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.
Microline Surgical is recalling ReNew Microscissor Tip (Disposable) lot 00172110 due to a 2% failure rate where the heat shrink breaks off.
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.
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.
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.
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.
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.
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.
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.
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.