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 10881–10900 of 38,428 recalls
Recalled Item: ExacTrac Dynamic software model numbers: 20910-01
The Issue: The yaw angle may be incorrect for CBCT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outer Packaging Label: Protekt Sharps Safety Knives - 44620MU
The Issue: Surgical knives may contain incorrect description printed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpaceOAR Vue System
The Issue: Users need to be aware that embolism is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpaceOAR System
The Issue: Users need to be aware that embolism is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Custom Procedure Kits containing BD Luer Lok Access Devices
The Issue: Recalled devices were packaged in convenience kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen floor
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee floor MN
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q ceiling
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q zeego
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee biplane
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee multi-purpose
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee biplane MN
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q floor
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee ceiling
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen biplane
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q biplane
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen ceiling
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee floor
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zeego
The Issue: If the coolant level in the cooling circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (a) CareFusion Snowden-Pencer Plastics
The Issue: The finished device package did not contain the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.