August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPIC GYN. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAP CHOLE PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls HVI CARDIAC ROBOT PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GYN ROBOTIC PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GYN LAPAROSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GS ENDOSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GENERAL ROBOTIC PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GEN LAPAROSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DAVINCI UROLOGY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DA VINCI PACK URO/PROSTATE. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls CT DAVINCI. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls CARDIAC ROBOT PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPIC TRAY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Hazard: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
August 13, 2025Medical DevicesFDA
Becton, Dickinson and Company, BD Bio Sciences recalls BD Trucount Controls, 30 Test - REF: 340335
Hazard: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
August 13, 2025Medical DevicesFDA
Becton, Dickinson and Company, BD Bio Sciences recalls BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Hazard: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3),
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02
Hazard: Laryngoscope handles may not illuminate as intended.
August 13, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60
Hazard: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
August 13, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Hazard: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
August 13, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Hazard: Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
August 13, 2025Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
Hazard: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
August 6, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-
Hazard: Potential for external cassette leaks