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 17301–17320 of 38,428 recalls
Recalled Item: ClubMax Laser Projection Series
The Issue: The User Remote Interlock Dongle provided with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grandio SO Heavy Flow Caps
The Issue: The metal cannula are potentially too loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is
The Issue: code 7-102 Liquid Sensor Error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3
The Issue: The action has been initiated to address reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
The Issue: of an open port in the quench
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3
The Issue: The action has been initiated to address reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
The Issue: of an open port in the quench
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
The Issue: of an open port in the quench
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
The Issue: of an open port in the quench
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3
The Issue: The action has been initiated to address reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3
The Issue: The action has been initiated to address reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACS Sample Prep Assistant (SPA) II - Product Usage:
The Issue: The recalling firm confirmed that BD FACS Sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACS Sample Prep Assistant (SPA) III - Product Usage:
The Issue: The recalling firm confirmed that SPA II and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACS Sample Prep Assistant (SPA) II Upgrade - Product
The Issue: The recalling firm confirmed that SPA II and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Cooled Laser Applicator System Tubing Set kits Product numbers:
The Issue: The firm received complaints on the saline tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GRIPPER Needles sold individually. Labeled as the following item descriptions:
The Issue: for certain GRIPPER Needles to contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN
The Issue: for certain GRIPPER Needles to contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TransWarmer Warming Infant Transport Mattress
The Issue: The firm updated the IFU in April 2019
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.