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 17741–17760 of 38,428 recalls
Recalled Item: Beckman Coulter Power Express Sample Processing System AU5800XL connection unit
The Issue: exposure to biohazard. Software design problem causes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip...
The Issue: Lidstock contains a labeling error. The lidstock shows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer version 5.0
The Issue: There is a potential that one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer with PACS-IW foundation 6.0
The Issue: There is a potential that one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 45 ARTICULATING XTRA THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 45 ARTICULATING MED THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 30 ARTICULATING MED THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 60 CURVED TIP ART MED THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 60 ARTICULATING EXTRA THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA 60 ARTICULATING MED THICK SULU
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EGIA45 CT AR MD THK REL
The Issue: The device may be missing one of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
The Issue: Incorrect coil length on the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Senographe Pristina - Product Usage: Senographe Pristina generates digital
The Issue: slippage of the biopsy positioner when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Pristina Serena - Product Usage: Pristina Serena is an
The Issue: slippage of the biopsy positioner when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer 6.0 Is a device that displays medical
The Issue: There is the possibility of viewing studies directly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.