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 17361–17380 of 38,428 recalls
Recalled Item: RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
The Issue: for a transducer mis-alignment in certain transvaginal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Repair RIC5-9A-RS System
The Issue: for a transducer mis-alignment in certain transvaginal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: daVinci XI Sureform 60 Reload
The Issue: The firm became aware of a manufacturing variation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: daVinci XI Sureform 60 reload
The Issue: The firm became aware of a manufacturing variation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Sexual Health Testing Kit
The Issue: A supplier informed PrivaPath Diagnostics that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris EtCO2
The Issue: Calibration; it has been determined that the capnographs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST -
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage:
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage:
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage:
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage:
The Issue: for sterile packaging to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch EasyCath Kit
The Issue: for product not to be sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.