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
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.
Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.