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 24861–24880 of 38,428 recalls
Recalled Item: ILLINOIS (TJ) NEEDLE ASPIRATION [15GA
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manometer
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
The Issue: During Ziehm Imaging GmbH FDA inspection, the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TotalCare Bed Systems
The Issue: The bed exit alarm may not function properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Enzyme 2 Calibrator
The Issue: Siemens Healthcare Diagnostics has confirmed a positive bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyto-Chex BCT - blood specimen collection device - Immunophenotyping...
The Issue: Complaints of the 2.0ml tube stopper coming loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The
The Issue: The 9.6F port kits were packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems
The Issue: When the user performs a retrospective respiratory gated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems
The Issue: Philips identified a 4D CT pulmonary phase issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY Internal Hex Healing Abutment
The Issue: Incorrect device was packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Medtronic StrataMR adjustable valves and shunts are designed to
The Issue: Incorrect valve rotor orientation due to misalignment and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Q
The Issue: In Artis systems with A100G generators, a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products VANC Reagent
The Issue: for biased results generated using the specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC FlexiView 8800
The Issue: OEC FlexiView 8800 workstation power cable assembly issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroAire K-Wires
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartTools Knee System Orthopedic Stereotaxic Instrument
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly Component Trial
The Issue: The dovetails of poly trials, Beta 2.0, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Software updates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.