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 15581–15600 of 38,428 recalls
Recalled Item: Gentell Hydrogel Ag 4x8
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal SECURITY CUFFS
The Issue: One lot of product was inadvertently manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The CapsoCam Plus (SV-3)
The Issue: Ingestible video capsule system has capsule with incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 3F Single-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 5F Dual-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 5F Dual-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 5F Triple-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 4F Single-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 5F Triple-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 4F Dual-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC KIT 5F Dual-Lumen
The Issue: The kits contain surgical gowns which were subject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearCanvas RIS/PACS
The Issue: A software defect negatively affects the quality of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Hip Cement Spacer Mold with Insert
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Hip Cement Spacer Mold with Insert
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Select
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synaptive ImageDrive Clinical
The Issue: A software defect negatively affects the quality of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Knee Femoral Cement Spacer Mold
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Select
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET StageOne Select
The Issue: Potentially insufficient cleaning process or potential inadequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.