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 21–40 of 38,428 recalls
Recalled Item: DxC 700 AU
The Issue: A delay in results may occur. When clinical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of:
The Issue: Due to complaints and investigations stating that alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units
The Issue: for rubber fragment detachment during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units
The Issue: for rubber fragment detachment during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN
The Issue: Fabric may experience premature delamination when using included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE
The Issue: Fabric may experience premature delamination when using included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029.
The Issue: During the bulk packaging process, some Luer Slip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITY II Laser System
The Issue: Reports of devices sparking/popping and potentially burning patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP Flex with SmartAssist. Product Code: 1000323.
The Issue: Differential pressure (dP) sensor in Impella RP devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP with SmartAssist. Product Code: 0046-0035.
The Issue: Differential pressure (dP) sensor in Impella RP devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP. Product Code: 0046-0011.
The Issue: Differential pressure (dP) sensor in Impella RP devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M12 System Model Numbers: (1)722078
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20 System Model Numbers: (1)722079
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 B12 System Model Numbers:(1) 722067
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 5 M12 System Model Numbers: (1)722227
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 3 M15 System Model Numbers: (1) 722064
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 3 M12 System Model Numbers: (1) 722063
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 B20 System Model Numbers: (1)722068
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 5 M20 System Model Numbers: (1)722228
The Issue: Under certain conditions, the table may move unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS300 IABP. Software Version CS300 IABP C.01.
The Issue: The firm has identified that the battery runtime
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.