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 15161–15180 of 38,428 recalls
Recalled Item: ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained
The Issue: Abbott identified that samples tested for ARCHITECT STAT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits packaged as a Piggy Back with
The Issue: DeRoyal manufactured procedure packs using BDPosiFlush syringes which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS icono systems with Quantification Application SW (QVA/QCA) on a
The Issue: Using Quantification Application (QVA/QCA) on DSA images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OLYMPUS ShockPulse-SE Lithotripsy System
The Issue: A component of the Olympus ShockPulse Transducer was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90
The Issue: The thermo switches in the three-phase transformer, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PosiFlush SF Saline Flush Syringe 10 mL used in
The Issue: Saline Flush Syringe compromised sterility due to holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pump Tube Set for MMS Libra and Solar Systems -
The Issue: This field correction is being initiated to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only
The Issue: Mapping Catheter can become entrapped in the cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx
The Issue: Mapping Catheter can become entrapped in the cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.