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 37581–37600 of 38,428 recalls
Recalled Item: Neptune 1 Silver Rover
The Issue: Stryker has received two reports of serious injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Neptune Bronze Rover
The Issue: Stryker has received two reports of serious injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune 1 Gold Rover (120 Vand 230V ) Waste Management
The Issue: Stryker has received two reports of serious injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system
The Issue: One of the four screws that secure the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An
The Issue: Impac Medical became aware of a problem with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots
The Issue: Siemens has confirmed that the Stratus(R) CS Acute
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager
The Issue: The recalling firm has discovered that when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyLink(TM) Informatics System
The Issue: There is a potential for the EasyLink system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Shot Epidural Trays
The Issue: Integra LifeSciences is recalling one lot of Single
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow International
The Issue: Arrow is recalling the product due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo.plaza radiological image processing system.
The Issue: Siemens became aware of an unintended behavior when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3
The Issue: Unit fails to power up, resulting in an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with
The Issue: The firm recalled because the glucose measurements from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Rigid Suction Wand
The Issue: Edwards is recalling Suction Wand models SPC2081 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered...
The Issue: Internal data identified a molding defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PathFinder NXT Pivoting Percutaneous Rod Holder This device is an
The Issue: Complaints have been reported where, during surgery, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pathfinder NXT Fixed Percutaneous Rod Holder
The Issue: Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Button Switchpens
The Issue: The carton label for this device has the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Button Switchpens
The Issue: The Tyvek pouch label for this device states:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pathfinder NXT Fixed Percutaneous Rod Holder
The Issue: Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.