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 18781–18800 of 38,428 recalls
Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM
The Issue: During manufacturing, the screw stop ledge was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM
The Issue: During manufacturing, the screw stop ledge was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM
The Issue: During manufacturing, the screw stop ledge was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM
The Issue: During manufacturing, the screw stop ledge was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity c Processing Module LN 03R67-01 - Product Usage:
The Issue: The safety interlock covering the septum piercing probes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity i Processing Module LN 03R65-01 - Product Usage:
The Issue: The safety interlock covering the septum piercing probes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIDEK Specular Microscope
The Issue: The electromagnetic noise exceeded the upper limit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach
The Issue: Updates to the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: xTAG Gastrointestinal Pathogen Panel intended for the simultaneous...
The Issue: Reports have been received of lower MS2 MFI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver
The Issue: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical
The Issue: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integrated ECG cable with 3-lead leadwires labeled as the following:
The Issue: The Integrated ECG cable with 3-lead leadwires can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop 1.25 Hex Drivers
The Issue: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop 1.25 Hex Drivers
The Issue: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith&Nephew SmartStitch PerfectPasser Connector
The Issue: The voluntary recall is being initiated due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.