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 34001–34020 of 38,428 recalls
Recalled Item: Synthes Driving Cap/Threaded Both parts are intended for use in
The Issue: The Synthes Driving Cap/Threaded can bind in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular...
The Issue: Defective component may cause extension sets to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infantino Squeeze & Teethe Monkey
The Issue: Infantino initiated this voluntary recall of all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gibralt Spine System Polyaxial Screw Intended to promote fusion of
The Issue: The products have been identified to contain springs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female
The Issue: Numerous complaints have been filed that leaking cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034
The Issue: Complaints were received regarding Quality Control (QC) shifts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
The Issue: The tracheal tube can kink during patient use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.