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 25461–25480 of 38,428 recalls
Recalled Item: TVC Imaging System model TVC-MC9
The Issue: Near-infrared spectroscopic image (Chemogram) generated by the TVC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 mm Distraction Pin
The Issue: Product's non-conformity involves the integrity of the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14 mm Distraction Pin
The Issue: Product's non-conformity involves the integrity of the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16 mm Distraction Pin
The Issue: Product's non-conformity involves the integrity of the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12 mm Distraction Pin
The Issue: Product's non-conformity involves the integrity of the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16 mm [or 18 mm] Distraction Pin
The Issue: Product's non-conformity involves the integrity of the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPS-1
The Issue: Organ preservation fluid recalled due to potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoTips 30g 20pk
The Issue: Ultradent Products, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: Software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Imager II Angiographic Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roth Net Polyp Retrieval
The Issue: The firm was notified that the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chord-X Chordal Sizer is designed to assist in determining the
The Issue: Four issues were uncovered by the recalling firm's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT X-4R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio mCT-S(40) 3R->4R Upgrade
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT-X w/TrueV Upgrade
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(40)-4R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(64)-4R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(64)-3R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT X-3R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOGRAPH mCT 20 Excel
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.