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 31281–31300 of 38,428 recalls
Recalled Item: Echostar Spica 1.5T MRI system
The Issue: The MRI system safety feature, which lowers the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI
The Issue: Labeling; The affected product packaging is incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Select Kits (ASK)
The Issue: Certain product codes and lot numbers of Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pilling Modular Verres Body/Obturator
The Issue: Packaging error in which customers who ordered product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 8100
The Issue: Units device head descended unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 8100 3D
The Issue: Units device head descended unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper...
The Issue: The taper adaptor is missing from the packaging,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This correction applies to all GE Healthcare MRI systems with
The Issue: At certain sites, the MRU may not be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cold Therapy Pad - cold water circulating pad
The Issue: Seals in the water path of the CT-99
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precise Digital Accelerator Intended to be used for radiation therapy
The Issue: Elekta has identified a batch of securing bolts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings
The Issue: Stryker is recalling System 6 Aseptic Housing, due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
The Issue: Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Ebb Complete Tamponade System
The Issue: Clinical Innovations, LLC is voluntarily recalling the Ebb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW Epidural Needle Component (product number AN-05501). Epidural needles...
The Issue: The product labeling does not specify the 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPWorks software used in the Xltek Protektor Stimulator Product Usage:
The Issue: Software error occurs when using remote monitoring; if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPWorks software used in the Protektor 32 Product Usage: Uses
The Issue: Software error occurs when using remote monitoring; if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE
The Issue: Combination of CTVision with syngo RT Therapist /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Blood Gas Analyzer
The Issue: Neonatal bilirubin (nBili) parameter may have increased variability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDLab 1265 System
The Issue: Neonatal bilirubin (nBili) parameter may have increased variability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.