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 261–280 of 38,428 recalls
Recalled Item: NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification...
The Issue: To remove the software applications from certain CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alphenix INFX-8000F
The Issue: It has been discovered that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alphenix INFX-8000H
The Issue: It has been discovered that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alphenix INFX-8000V
The Issue: It has been discovered that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alphenix INFX-8000C
The Issue: It has been discovered that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tego Connector:
The Issue: Needle free access device intended as accessory to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column
The Issue: The supplier manufactured anatomical left plates with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM
The Issue: Due to products not having FDA Premarket authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column
The Issue: The supplier manufactured anatomical left plates with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
The Issue: There is a potential for formation of ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pulsator Arterial Blood Sampling Kit
The Issue: Affected lots of syringes may have a crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
The Issue: There is a potential for formation of ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Spinal Tray
The Issue: Affected lots of syringes may have a crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gelsoft Plus
The Issue: Gelatin sealed woven polyester prostheses devices, designed for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teslatome Bipolar Sphincterotomes Model Number: G60784 UDI-DI code:
The Issue: Due to product that may contain a void
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton Equipment
The Issue: for fraying on the body support strap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton Equipment
The Issue: for fraying on the body support strap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton Equipment
The Issue: for fraying on the body support strap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlternatiV+ Screw-In Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Push-In Suture Anchor
The Issue: Reports of device failure, including anchor breakage, anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.