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
GE HealthCare recalls certain SIGNA MRI systems because maintenance procedures to verify caster lock functionality on patient tables may not have been performed. Affected units underwent planned maintenance since March 1, 2023.
SPINEART SA is recalling PERLA TL MIS Cannulated Fenestrated Polyaxial Screws (Model MPF-PS 65 40-S, Lot 8-4528) due to incorrect labeling. Affected units were distributed nationwide in Florida, Kentucky, and California.
GE HealthCare recalled Discovery MR450 1.5T MRI systems due to planned maintenance checks on patient table caster locks that may not have been performed, potentially compromising table stability.
GE HealthCare is recalling certain MR imaging systems because maintenance steps to verify caster lock functionality on the patient table may not have been performed.
Diversatek Healthcare is recalling the Zvu Anorectal Manometry Procedure Kit (Lot 24752) because the outer kit label displays an incorrect expiration date using the manufacturing date instead. The correct expiration date appears on inner kit labels.
Flexicare Medical is recalling BritePro Solo Mini laryngoscope handles because they may not illuminate as intended. Affected units were distributed nationwide from July 2020 to December 2020.
BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate and bolus accuracy, potentially delivering incorrect medication doses. Patients and healthcare providers should contact CareFusion.
Flexicare Medical is recalling BritePro Solo Single-Use Fiber Optic Laryngoscope Handles because the illumination may not function as intended, which could affect their intended use.
The BD Alaris Pump Module 8100 may deliver medication at incorrect flow rates, inaccurate bolus volumes, and may fail to detect occlusions on time. Over 33 million units are affected.
B. Braun Medical is recalling 34,825 Microbore Extension Sets due to incorrect labeling claiming air-eliminating capability the device does not possess.
Approximately 4,677 Plum Duo Infusion Systems may experience user interface unresponsiveness due to programming events and alarm interactions. Users should contact ICU Medical for guidance on affected units.
Flexicare Medical is recalling BritePro Solo single-use fiber optic laryngoscope handles manufactured July–December 2020. The handles may not illuminate, preventing proper visualization during airway procedures.
Flexicare Medical is recalling BritePro Solo Mini laryngoscope handles because the illumination may fail. These surgical devices, critical for safe intubation, might not light up during procedures.
Flexicare Medical is recalling certain Britepro Solo laryngoscope handles that may fail to illuminate properly. Affected devices were distributed nationwide from July through December 2020.
Flexicare Medical is recalling BritePro Solo Single-Use Fiber Optic Mini Handle and Blade laryngoscope handles due to potential illumination failure. Affected units were manufactured between July and December 2020.
AVID Medical's GYN ROBOTIC PACK medical convenience kits have been recalled due to inadvertent resterilization causing discoloration of the visualization system. The recall affects 45 units distributed in six states.
Beckman Coulter's DxI 800 immunoassay analyzers with certain software versions have a motor current setting that incorrectly resets during updates, potentially delaying patient test result reporting.
AVID Medical is recalling 292 LAVH Pack surgical kits due to inadvertent resterilization that caused discoloration of the CLEARIFY VISUALIZATION SYSTEM. Affected kits were distributed in seven U.S. states.
Beckman Coulter DxI 800 analyzers may have incorrect motor current settings that reset during software updates, potentially delaying patient sample result reporting.
Becton, Dickinson is recalling BD Trucount Control kits with incorrect standard deviation values that compromise the accurate calculation of bead counts. The recall affects kits distributed worldwide including the United States.
AVID Medical is recalling 46 robotic partial nephrectomy surgery kits due to inadvertent re-sterilization of the visualization system component, which caused discoloration.
AVID Medical is recalling the GS Endoscopy Pack due to inadvertent resterilization that caused discoloration of the visualization system. The recall affects 816 units distributed across seven states.
AVID Medical is recalling laparoscopic prostatectomy convenience kits distributed to seven states because the CLEARIFY VISUALIZATION SYSTEM component was inadvertently resterilized, causing discoloration that may affect surgical visualization.
Intersurgical Inc is recalling 2,800 Guedel airways (Model 1112080, Lot 32414447) due to potential small burrs that could detach and be inhaled, causing airway obstruction or tissue damage. No injuries have been reported.
AVID Medical is recalling 372 Robotic Uro/Gyn Packs in which the visualization system was inadvertently resterilized, causing discoloration. Affected products were distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.