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 1341–1360 of 38,428 recalls
Recalled Item: Allura CV20
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10 Product Codes: (1)722010
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 OR Table Product Codes: (1)722023
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/20 OR Table
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 Biplane OR Table Product Codes: (1)722020
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 Product Codes: (1)722012
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/20
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/10
The Issue: Systems may not perform as intended due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tribio Implant 7.5mm x 40mm SB008 UDI code:
The Issue: Due to incorrect product label (Incorrect product name
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This device is a digital radiography/fluoroscopy system used in a
The Issue: It has been found that when SPOT Fluoro
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616
The Issue: The bovine carotid arteries used to produce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK System Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM EXTENSION SET
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK System Paclitaxel Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONTINU-FLO Solution Set
The Issue: IV sets may leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.