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 36881–36900 of 38,428 recalls
Recalled Item: qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2
The Issue: Spacelabs Healthcare has learned through several reports that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriVascular brand Fill Polymer Kit
The Issue: Selected lots of the Fill Polymer Kit (European
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling
The Issue: American Medical Systems¿ (AMS) is issuing a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 16 Multi-Sliced CT Scanner System
The Issue: The four screws that secure the patient table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric
The Issue: Complaint received from sales representative that the drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PARPARELLA-TYPE VENT TUBE
The Issue: One lot of tympanostomy tubes were manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injections
The Issue: The firm inventoried and distributed 0.9% Sodium Chloride
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal
The Issue: Thirty fetal scalp electrodes were found to have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.