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 15541–15560 of 38,428 recalls
Recalled Item: TandemHeart pump is assembled into kits: TandemLung Kit - DL31
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart Pump Kit
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15
The Issue: Failure to prime due to an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chest Support for R82 Mustang
The Issue: The plastic plug on the chest support for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL800 FLEX model number 393-800 and 393-801
The Issue: Through internal investigation is has been determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum Central Venous Catheter Tray
The Issue: The printed expiration dates are incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pericardiocentesis Set
The Issue: The printed expiration dates are incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRx4841A 1.4 GHz IntelliVue Tele TRX
The Issue: The ECG signal from patients being monitored using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRx4851A 2.4 GHz IntelliVue Tele TRX
The Issue: The ECG signal from patients being monitored using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phillips Azurion 7 M20
The Issue: No torque was specified for the four screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended
The Issue: The Coupler size labeling of the outer tray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Microvascular Anastomotic Coupler Devices s intended to be used
The Issue: The Coupler size labeling of the outer tray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended
The Issue: The Coupler size labeling of the outer tray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips V60 Ventilators with Power Management PCBA part number 1055906
The Issue: Solder connection failure on Power Management printed circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: natus newborn care Olympic Brainz Monitor
The Issue: The OBM system functional test (impedance and noise)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.