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 2441–2460 of 38,428 recalls
Recalled Item: The Alinity m System is designed to automate the steps
The Issue: The design of the Alinity m System Solutions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed
The Issue: There have been at least 12 complaints from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cerene Cryotherapy Device Product Name: DEVICE
The Issue: Due to evaporator gasket not sealing which can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GenetiSure Dx Labeling Kit
The Issue: DNA Labeling Kit for use in sample labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile 0.9% Normal Saline
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile Water
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Informatics - VIPER Product Name: Monitor
The Issue: Medical device software marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
The Issue: The occurrence of discrepant high pH results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor
The Issue: Medical device software marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline procedure kits
The Issue: It was identified that the Medline Sterile Water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System
The Issue: The occurrence of discrepant high pH results in
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.