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 1521–1540 of 38,428 recalls
Recalled Item: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000.
The Issue: Reports of out-of-box failures discovered during the limited
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The
The Issue: for undetected, deformed a-traumatic tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reef TA Inserter
The Issue: Inserter, used as part of a system with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DLP Left Heart Vent Catheter Malleable body and vented connector
The Issue: The catheters may not retain their shape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical CADD Medication Cassette Reservoir with clamp and female
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical CADD Medication Cassette Reservoir with flow stop
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical CADD Medication Cassette Reservoir with clamp and female
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DLP Left Heart Vent Catheter Malleable body and vented connector
The Issue: The catheters may not retain their shape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical CADD" Medication Cassette Reservoir with flow stop
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop
The Issue: Certain CADD 50 mL and 100 mL Medication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DLP Left Heart Vent Catheter Malleable body and vented connector
The Issue: The catheters may not retain their shape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to incomplete seals in the pouch which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to incomplete seals in the pouch which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to incomplete seals in the pouch which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to incomplete seals in the pouch which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to incomplete seals in the pouch which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 insulin pump with Interoperable Technology
The Issue: A software defect in versions 7.9.0.1 and 7.10.1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle Radiation Therapy Planning System: Multimodality Simulation...
The Issue: Due to a software issue, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific NephroMax Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.