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.
Minimum severity
AVID Medical is recalling Partial Nephrectomy Packs (52 units) because the CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized, causing discoloration.
Intersurgical Inc is recalling Guedel Airway Size 3 (Model 1113090) due to potential contamination with small burrs that could detach and be inhaled, causing airway obstruction or tissue damage. Approximately 8,640 units were affected.
AVID Medical is recalling the CARDIAC ROBOT PACK medical convenience kit after inadvertent resterilization caused discoloration of the visualization system. Twenty units distributed across seven U.S. states are affected.
Siemens Healthcare Diagnostics Inc. is recalling epoc BGEM BUN Test Cards from certain lots because of a negative sodium bias that may produce inaccurate results. The average measured bias was -4.4 mmol/L, with a maximum of -14 mmol/L.
AVID Medical is recalling its DA VINCI PACK URO/PROSTATE surgical kits because the visualization system was inadvertently resterilized, causing discoloration.
Beckman Coulter's UIBC assay does not meet its labeled performance claims for hemoglobin interference. Testing showed up to 43.6% negative bias in low UIBC samples at 200 mg/dL hemoglobin, versus the claimed <10% interference limit.
AVID Medical is recalling laparoscopic trays because the visualization system became discolored from inadvertent resterilization. Forty units were distributed to healthcare facilities in CA, IL, MD, OH, PA, TX, and WA.
AVID Medical is recalling 574 General Laparoscopy Trays due to inadvertent resterilization causing discoloration of the CLEARIFY VISUALIZATION SYSTEM. The discoloration could compromise surgical visibility.
AVID Medical, Inc. is recalling 321 units of GEN LAPAROSCOPY PACK kits distributed in six states due to discoloration of the visualization system caused by inadvertent resterilization.
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software defect causing incorrect motor current settings that may delay patient sample result reporting. The issue affects systems running software versions 5.7 and later.
AVID Medical is recalling 452 Laparoscopy Pack units distributed to medical facilities in seven U.S. states due to inadvertent resterilization causing discoloration.
AVID Medical is recalling 128 Major Thoracoscopy Basin medical convenience kits due to discoloration caused by inadvertent resterilization during manufacturing.
Nuclein LLC is recalling DASH SARS-CoV-2 & Flu A/B Test kits due to a manufacturing error that may produce false negative results, potentially delaying diagnosis and treatment.
AVID Medical is recalling GENERAL ROBOTIC PACK medical kits due to discoloration of the CLEARIFY VISUALIZATION SYSTEM caused by inadvertent resterilization. A total of 203 units were distributed across seven states.
Stryker SmartPump Tourniquet cuff flanges may detach during use, causing potential hemorrhage and cardiovascular collapse. Distributed nationwide and internationally.
Philips is recalling Pinnacle 3 radiation therapy planning software due to a software bug that may provide incorrect stopping power ratio calculations. Affected users should contact the manufacturer and verify treatment plans.
AVID Medical is recalling laparoscopic gynecology kits due to improper resterilization that caused discoloration. The recall affects 18 units distributed across several states.
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software issue causing incorrect motor current settings that lead to motion errors and potential delays in patient sample reporting. The recall affects 177 systems worldwide.
AVID Medical is recalling DAVINCI UROLOGY medical convenience kits because they were inadvertently resterilized, causing discoloration. The recall affects 166 units distributed domestically.
AVID Medical is recalling CT DAVINCI Medical convenience kits that were inadvertently resterilized during manufacturing, causing discoloration. The kits were distributed domestically in seven states.
AVID Medical is recalling 656 PACK GENERAL ROBOTIC medical convenience kits that were inadvertently resterilized, causing discoloration. The defective kits were distributed in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
AVID Medical is recalling 626 DAVINCI TRUCUSTOM BUNDLE medical kits because the CLEARIFY VISUALIZATION SYSTEM was inadvertently re-sterilized, causing discoloration. Affected units were distributed in CA, IL, MD, OH, PA, TX, and WA.
DRG International is recalling 47 units of T4 Total ELISA kits due to labeling errors. The box label and Certificate of Analysis incorrectly show an expiration date of March 31, 2026, but the actual shelf life of the reagents is January 31, 2026.
Beckman Coulter's UniCel DxI 800 analyzer has a software defect causing the motor current to reset to 1.5A instead of 2.0A during updates, potentially delaying patient sample reporting. Affected devices require remediation.
AVID Medical is recalling ROBOTIC PROSTATECTOMY PACK units due to inadvertent resterilization of the CLEARIFY VISUALIZATION SYSTEM, which caused discoloration. The kits were distributed domestically.