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 34661–34680 of 38,428 recalls
Recalled Item: Medtronic Activa PC
The Issue: Medtronic notified customers regarding over stimulation or stimulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard LifeStent Solo Vascular Stent
The Issue: Bard Peripheral Vascular is recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Introcan Safety IV Catheter PUR 24G
The Issue: One lot of Introcan Safety IV Catheters may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TB-0545PC: THUNDERBEAT 5 mm
The Issue: Complaints of damage to various models of Thunderbeat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniPod Insulin Management Product Demonstration Kit
The Issue: Alcohol Prep Pads contained within the kit are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniPod Insulin Management System Starter Kit
The Issue: Alcohol Prep Pads contained within the kit are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis OPTEASE Vena Cava Filter Is indicated for use in
The Issue: Cordis identified a printing error on one unit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breeze C Scooter is a motorized electric scooter for elderly
The Issue: Breeze C Scooter, motorized 3-wheeled electric scooter for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distal Access Catheter: Model Numbers: 90121
The Issue: Distal Access Catheters were shipped to US customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.5MM LOCKING SCREW
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz
The Issue: Manufacturer defined limits for improperly functioning loudspeakers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon
The Issue: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter
The Issue: Incomplete foil seal on one lot of sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arena-L 35x26 Trial Head I 10¿ Lordotic
The Issue: Handles and heads may not be compatible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arena-L Trial Handle
The Issue: Handles and heads may not be compatible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arena-L 38x28Trial Head I 10¿ Lordotic
The Issue: Handles and heads may not be compatible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shortened Plug Driver
The Issue: Biomet received a complaint on 5/20/2013 reporting that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct
The Issue: Siemens Healthcare Diagnostics is conducting a field correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy
The Issue: The potential exists for the locking screw nut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench
The Issue: Multiple complaints have reported that the hex tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.