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 34981–35000 of 38,428 recalls
Recalled Item: ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it
The Issue: Siemens determined that if an autosampler rack jam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction
The Issue: Due to a labeling error related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vygon 14 Microbore Extension Set with Bionector
The Issue: Microbore tubing disconnecting from male luers on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Dressing Change Kit
The Issue: Microbore tubing disconnecting from male luers on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T8 REMOVAL HEAD
The Issue: One lot of the T8 Removal Head had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steinmann Pin
The Issue: A medical device used in surgical procedures was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kirschner-Wire (K-Wire)
The Issue: A medical device used in surgical procedures was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VARISOURCE Breast Template System for high-dose rate Brachytherapy....
The Issue: The recall was initiated after Varian Medical became
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes
The Issue: OPTI LION E-Plus Cassettes were labeled with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonogage EyeScan
The Issue: During an FDA inspection on 7/15-26/2013, it was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument
The Issue: The recall of the WASP (Walk Away Specimen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon 24 Large Titanium Clips with Adhesive Backing
The Issue: The manufacturing and expiration dates are not printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Easy Upgrade DR
The Issue: The mirror icon on the bottom of each
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe
The Issue: Manufacturer made a change in the production process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips MR Systems: Asset 0.5T
The Issue: There is a potential for water to collect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS.
The Issue: Megadyne Medical Products is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to
The Issue: GE has recently become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.