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 26321–26340 of 38,428 recalls
Recalled Item: LipiFlow thermal Pulsation System
The Issue: Complaints related to an error condition occurring during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian Head Frame - Model number HHF -ALL Head Frame
The Issue: Varian Medical Systems has received a report that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be
The Issue: A&D may have shipped blood pressure monitors that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SB (Sumitomo Bakelite Co.
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SB Knife -Electrosurgical Knife
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Percuaneous Solutions
The Issue: The product is being recalled due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
The Issue: Two customer complaints suggest that excessive rotation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Percuaneous Solutions
The Issue: The product is being recalled due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001...
The Issue: Greatbatch Medical has identified an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TD60 display Telemetry Transmitter
The Issue: Mindray has become aware that the TD60 Display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire
The Issue: The supplier initiated a recall because affected lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celerity ECG Cable Accessory Pack
The Issue: The Celerity ECG Cable Accessory Pack has the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo
The Issue: Ortho confirmed that it is possible for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily...
The Issue: The device has the potential to be packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IgE Calibrator Series
The Issue: According to the firm, the IgE Calibrator Series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Software upgrade to eliminate several issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS CL Flow Cytometer
The Issue: Beckman Coulter is recalling the AQUIOS CL System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.