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 31381–31400 of 38,428 recalls
Recalled Item: Covidien Trellis-8 Peripheral Infusion System. Models CVT808015
The Issue: A manufacturing error resulted in the risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16cm Minimally Invasive Attachment. For use with Motor Systems for
The Issue: Customer complaint indicating the color bands on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01
The Issue: A manufacturing error resulted in the risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: unintentional system motion or rotation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem 10 SG Urine Chemistry Strips
The Issue: Iris International is recalling the iChem 10 SG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Integrated APD Set with Cassette 3-Prong
The Issue: Baxter is issuing a recall for one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX analyzer
The Issue: The ABL90 analyzer does not always use the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Airo Mobile Intraoperative CT I Airo
The Issue: There is a risk that during the transfer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Brilliance and Ingenuity Computed Tomography X-ray systems
The Issue: Improper assembly of the vertical motor/brake system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osteobond Bone Cement Bone cement monomer is kitted with bone
The Issue: Samples of product from Supplier lot 14D0809 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G- Series Beds
The Issue: Invacare identified that the rail mounting bracket on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verasense Knee System
The Issue: Presence of one inoperable (dead) sensor pad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IS3000 Vision Side Cart (VSC) used in conjunction with the
The Issue: Intuitive Surgical is initiating a voluntary correction related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio PT/INR Test Strips
The Issue: In certain cases, an INRatio PT/INR Monitor system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional
The Issue: In certain cases, an INRatio PT/INR Monitor system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional -
The Issue: In certain cases, an INRatio PT/INR Monitor system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DBX Mix
The Issue: The seal on the DBX Mix outer PETG/Aclar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET Servo Humidifier 163
The Issue: Connector mount cracks which may lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3 Protege Rx Tapered Carotid Stent System
The Issue: Two production lots of the Protege Rx Tapered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.