Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IILAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IILAPAROSCOPIC GYN. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IILAP CHOLE PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIHVI CARDIAC ROBOT PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGYN ROBOTIC PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGYN LAPAROSCOPY PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGS ENDOSCOPY PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGENERAL ROBOTIC PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGENERAL LAPAROSCOPY TRAY. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIGEN LAPAROSCOPY PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIDAVINCI UROLOGY. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIDAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IIDA VINCI PACK URO/PROSTATE. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IICT DAVINCI. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IICARDIAC ROBOT PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DeviceAVID Medical, Inc.Class IILAPAROSCOPIC TRAY. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 2025-08-13FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIPinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- 2025-08-13FDA-DeviceBecton, Dickinson and Company, BD Bio SciencesClass IIBD Trucount Controls, 30 Test - REF: 340335
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- 2025-08-13FDA-DeviceBecton, Dickinson and Company, BD Bio SciencesClass IIBD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceFlexicare Medical (Dongguan) Ltd.Class IBritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
Laryngoscope handles may not illuminate as intended.
- 2025-08-13FDA-DeviceCareFusion 303, Inc.Class IBD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, S
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.
- 2025-08-13FDA-DeviceCareFusion 303, Inc.Class IBD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
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.
- 2025-08-13FDA-DeviceB BRAUN MEDICAL INCClass IMicrobore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
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.
- 2025-08-13FDA-DeviceICU Medical, Inc.Class IPlum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- 2025-08-06FDA-DeviceFresenius Kabi USA, LLCClass IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
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