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
Encore Medical is recalling both knee and shoulder implants due to incorrect labeling. Affected patients should contact their healthcare provider for guidance.
Encore Medical is recalling RSP HUMERAL SOCKET INSERT implants (Model 509-00-432, Lot 385P1263) due to incorrect labeling. The implants were distributed nationwide across multiple states.
Encore Medical is recalling EMPOWR 3D KNEE implants due to incorrect labeling. Patients and healthcare providers should contact the manufacturer for guidance.
Edermy LLC is recalling the PIE Trolley System Model 2005 because the device was distributed without required FDA 510(k) clearance. The recall affects 27 units distributed nationwide across 18 states.
Olympus is recalling 485 High Flow Insufflation Units nationwide due to a software algorithm defect that may cause overpressure during laparoscopic surgery.
Olympus Corporation recalls 744 High Flow Insufflation Units (Model UHI-2) nationwide due to a software algorithm issue that may cause overpressure events during laparoscopic surgery.
Olympus Corporation recalled 18 High Flow Insufflation Units nationwide due to a software algorithm issue that may lead to overpressure events during laparoscopic surgery.
Medline is recalling surgical drape packs due to sterilization equipment calibration issues that could compromise sterility levels. No illnesses have been reported.
Olympus Corporation of the Americas is recalling 3,381 units of its Olympus Thunderbeat surgical instrument worldwide due to continued reports of adverse events.
Medline is recalling 684 surgical convenience kits due to equipment calibration issues that may have compromised sterility assurance levels. Affected devices may not meet required sterilization standards.
Medline Industries is recalling 926,227 units of IV Administration and Extension Sets due to potential male luer connector defects that may leak, crack, or break during use, risking treatment delays, infection, blood loss, or air embolism.
Wilson-Cook is recalling Teslatome Bipolar Sphincterotomes due to material voids that could cause inappropriate electrical current during cutting procedures. The recall affects 153 units distributed in four U.S. states.
Medline is recalling 108 Convenience Kits nationwide due to sterilization equipment calibration defects that could compromise sterility assurance on medical closure devices.
Integra LifeSciences is recalling CVS private-label wound dressing (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier. No injuries have been reported.
Medline is recalling 82,597 surgical device kits nationwide due to equipment calibration issues that could affect sterilization quality. The kits were used in various surgical procedures.
Olympus is recalling the Thunderbeat surgical device model TB-0520IC due to continued reports of adverse events. The recall affects 140 units distributed worldwide.
Medline is recalling 753 tracheostomy convenience kits due to calibration issues in sterilization equipment that could affect sterility assurance level.
Medline has recalled lithotomy packs due to calibration issues with sterilization equipment that may compromise sterility assurance. Affected units were distributed nationwide and worldwide.
Medline is recalling approximately 7,575 PPE Convenience Kits (Model DYK1011945P) due to sterilization equipment calibration issues that may compromise device sterility. Affected products were distributed nationwide.
Medline is recalling 9,720 sterilized medical device kits due to sterilization equipment calibration problems that may compromise their sterility assurance levels.
Medline is recalling Dental Pack convenience kits (Model DYNDA3003) due to calibration issues in sterilization equipment that may compromise sterility assurance. Healthcare providers should stop use and contact Medline for replacement.
Medline is recalling a triple lumen catheter insertion kit (Model DYNDM1031A) due to potential sterility issues caused by equipment calibration problems during sterilization and packaging.
Certain lots of Estrone RIA diagnostic kits may rarely produce falsely elevated test results that could lead to temporary injury in rare cases. The kits were distributed worldwide including North Carolina.
Olympus Corporation is recalling 4,181 units of the Olympus Thunderbeat 5mm surgical device due to continued reports of adverse events. The device was distributed across the U.S., Brazil, Canada, Germany, Mexico, and Japan.
Medline is recalling 4,757 surgical kits and packs due to calibration issues with sterilization equipment that could affect sterility assurance. No illnesses or injuries have been reported.