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 30801–30820 of 38,428 recalls
Recalled Item: Ebola GP IgX Blood
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola Virus Antigen Blood
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola Virus GP-VP IgS
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette)
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola Virus Antigen Nasal
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pluer-evac Sahara Chest Drainage System
The Issue: Package contains incorrect sized unit: The adult sized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola GP IgM Blood (Blood Serum/Plasma/Cassette)
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polaris 4.75 TI Spinal System
The Issue: Multiaxial screws may not meet internal requirements related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panorama Patient Monitoring Network
The Issue: Software anomaly in the Panorama System software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage:
The Issue: Biomet is recalling the Lineum HF Torque Handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct
The Issue: Biomet is recalling the Lineum HF Torque Handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC units
The Issue: CareFusion is recalling the Alaris PC unit because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABG-HM-1 Hummi Micro Draw Blood Transfer Device
The Issue: Hummingbird Med Devices, Inc. is recalling the Hummi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging
The Issue: It was noticed that the spectroscopy voxel map
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO
The Issue: The firm was notified by a customer that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpress System Pedicle Screw Assembly
The Issue: One lot of instruments have etched on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000V Interventional Angiography System. CAT-880B catheterization...
The Issue: The table base rotational brake that holds the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software Version 2.8 & Below on VITROS 5
The Issue: Software Anomaly; It is possible for the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talon Grasping Device
The Issue: A wire component on the distal grasping assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.