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 23161–23180 of 38,428 recalls
Recalled Item: 120" (305cm) Y-Type Blood Set w/170 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 119" Blood Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 159" (404 cm) Y-Type Blood Set w/170 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 88" (224 cm) Y-Type Blood Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM
The Issue: The foot control used on the OAKWORKS¿ Inc.,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Tray Triple Lumen Polyurethane Catheter
The Issue: Central venous catheters may not fit over guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane
The Issue: Central venous catheters may not fit over guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheter Set Triple Lumen Polyurethane
The Issue: Central venous catheters may not fit over guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheter Tray Triple Lumen Polyurethane
The Issue: Central venous catheters may not fit over guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic...
The Issue: Central venous catheters may not fit over guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic
The Issue: Siemens has identified an issue when scanning the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas 8000 Modular Series system
The Issue: A software failure may incorrectly set the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIRO Mobile CT System
The Issue: Risk of unintended motion while the AIRO system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rezum System
The Issue: Needle Bond may not be able to withstand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female
The Issue: Specific lots labeled as an Antibacterial Hydrophilic Intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convertors Robotic Drape with Attached Leggings
The Issue: Product 29474 LAVH drape was packaged as 29574
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB
The Issue: There is a potential for the over-pressure safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK
The Issue: There is a potential for the over-pressure safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB
The Issue: There is a potential for the over-pressure safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.