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 31721–31740 of 38,428 recalls
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Electric Drive (SED)
The Issue: May operate solely in reverse mode, not operate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered stretcher chair used during facial and eye surgeries. One
The Issue: The firm is finding that the stretcher chair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLUTTER Percussor respiratory device
The Issue: Customer notification that the device may be difficult
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Reagent Container
The Issue: HORIBA Medical is recalling the ABX PENTRA 400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illumina MiSeqDx Universal Kit 1.0
The Issue: It was discovered a software limitation with MiSeq
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT X-4R
The Issue: Possibility for system display freeze during CT interventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT Flow 40-4R
The Issue: Possibility for system display freeze during CT interventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(40)-4R
The Issue: Possibility for system display freeze during CT interventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(64)-4R
The Issue: Possibility for system display freeze during CT interventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT Flow Edge-4R
The Issue: Possibility for system display freeze during CT interventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml
The Issue: Use of the product could result in inadequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView model number: 882478 BrightView X model number: 882480 BrightView
The Issue: Unintended detector and gantry movement due to software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Revolution CT is a multi-slice (256 detector row) CT
The Issue: A required quality control test was not performed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.