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 2461–2480 of 38,428 recalls
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ballard Product Name: Closed Suction Catheters Model/Catalog Number:
The Issue: Lack of sterility assurance for closed suction catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM
The Issue: Integrated Lag/Compression Screw Kit has a compression screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Semi-Automated External Defibrillators
The Issue: It was noticed there was no Italian translation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated External Defibrillators
The Issue: It was noticed there was no Italian translation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated External Defibrillators
The Issue: It was noticed there was no Italian translation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated External Defibrillators
The Issue: It was noticed there was no Italian translation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated External Defibrillators
The Issue: It was noticed there was no Italian translation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:
The Issue: When expired reagents are scanned or manually entered,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:
The Issue: When expired reagents are scanned or manually entered,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:
The Issue: When expired reagents are scanned or manually entered,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:
The Issue: When expired reagents are scanned or manually entered,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:
The Issue: When expired reagents are scanned or manually entered,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Clinical Chemistry Analyzer
The Issue: The reason for the recall is incorrect sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplatzer TorqVue LP Delivery System (TVLP)
The Issue: Device may have a small breach in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplatzer TorqVue LP Catheter (TVLPC)
The Issue: Device may have a small breach in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.