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 23201–23220 of 38,428 recalls
Recalled Item: Syngo Imaging version V31 (model # 10014063) is a Picture
The Issue: Siemens is releasing a letter to inform about
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artholine Punch B 4
The Issue: Punch may have a burr in one section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3-Way Standardbore Stopcock. Product Code: AMS-100.
The Issue: Vygon is conducting a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
The Issue: Vygon is conducting a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
The Issue: Vygon is conducting a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
The Issue: Vygon is conducting a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen LPS Femoral Component
The Issue: There is a possibility that the protective foam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
The Issue: Vygon is conducting a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Replacement
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX-2 COUDE Epidural Needle
The Issue: for partially incomplete seal of product, impacting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TUOHY Epidural Needle
The Issue: for partially incomplete seal of product, impacting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COUDE Blunt Nerve Block Needle
The Issue: for partially incomplete seal of product, impacting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium VR DF4 1240
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium CRT-D 1741
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium DR DF4 1540
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium VR 1210
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium CRT DF1 1711
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Platinium DR 1510
The Issue: There is a possibility of overconsumption of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Laser Laser Light Show projector models Aurora
The Issue: Failure to comply with performance standard requirements (21
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard
The Issue: The Cardan joint of the Polarstem Cardan could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.