Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 9741–9760 of 38,428 recalls
Recalled Item: Arrow AutoCAT 2 Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerate PhenoTest BC kit
The Issue: Due improperly formulated and released bulk lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerate PhenoTest BC kit
The Issue: Due improperly formulated and released bulk lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS)
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam...
The Issue: Broken Optical fiber cable damage can occur through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope...
The Issue: Broken Optical fiber cable damage can occur through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18239: ASM Omnipod Dash PDM
The Issue: The firm has become aware of PDM battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to
The Issue: Two electronic diode components (D1 & D4) placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extension Tabletop for Operating Table System 1140
The Issue: The back rest may unintentionally drop suddenly, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER
The Issue: Due to a defect in the outer pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GentleWave System APM Procedure Instrument with Matrix
The Issue: Procedure Instruments with erroneous unit carton labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GentleWave System Posterior CleanFlow Procedure Instrument with Matrices...
The Issue: Procedure Instruments with erroneous unit carton labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Laser System
The Issue: Laser System may detect Error 106 or Error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for
The Issue: Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Con
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.