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 12021–12040 of 38,428 recalls
Recalled Item: Cordis SUPER TORQUE MB 5F PIG
The Issue: Cordis has identified that the SUPER TORQUE MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL
The Issue: Cordis has identified that the SUPER TORQUE MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis SUPER TORQUE MB 5F PIG
The Issue: Cordis has identified that the SUPER TORQUE MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MERITMEDICAL Prelude Short Sheath Introducer
The Issue: There is a potential that a package sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CritiCool
The Issue: Premature pump failure may lead to the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent...
The Issue: If the device is exposed to fluid ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solero Generator US PG
The Issue: Specific serial numbers of the Solero MTA Generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nihon Kohden NKV-550 Ventilator
The Issue: defective gas inlet pressure regulator within ventilator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solero Generator US PG
The Issue: Specific serial numbers of the Solero MTA Generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solero Generator PG
The Issue: Specific serial numbers of the Solero MTA Generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solero Generator PG
The Issue: Specific serial numbers of the Solero MTA Generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions
The Issue: An internal component may be cracked and become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue
The Issue: An internal component may be cracked and become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label:...
The Issue: Due to product complaints received for false negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis SABER PTA Balloon Dilation Catheter
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: Infant/Child defibrillator pads contain incorrect labeling. This could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set
The Issue: The firm received reports that the endotracheal tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH Endotracheal Tube oral/nasal Murphy Eye
The Issue: The firm received reports that the endotracheal tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.