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 34941–34960 of 38,428 recalls
Recalled Item: POWERWAND Safety Introducer with Extended Dwell Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 10 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 100 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 100 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 10 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 100 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 10 Units/mL Heparin Lock Flush
The Issue: Monoject prefill flush syringes may contain non-sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmony Equipment Management System
The Issue: Dr¿ger Medical GmbH has notified STERIS of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
The Issue: The manufacturer has conducted a review of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
The Issue: Clinical mistreatment may occur when there are errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEART CATH CUSTOM PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATH TRAY
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATH PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE SAMPLE BUILD
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE SAMPLE BUILD
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATH PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE SAMPLE CATH LAB PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.