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 19741–19760 of 38,428 recalls
Recalled Item: Dimension Lipase Flex Reagent Cartridge
The Issue: There is lot to lot variability for QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codan Filter (Codan catalog number BC 693) used with Medrad
The Issue: Bayer has received reports of loose particulate in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct Scan Adapter Assembly Replant platform for the following
The Issue: The action is being initiated due to incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heating Profile PRISMAFLO II S blood return warmer for Prismaflex
The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heating Profile PRISMAFLO II S blood return warmer for Prismaflex
The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product
The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altrix¿ Precision Temperature Management System Model: 8001Product Usage:...
The Issue: Users may experience alarm fatigue due to frequent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoPatch SG Pulmonary Hemi-Artery
The Issue: The conduit length and branch length of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is
The Issue: Product may not meet the internal manufacturing shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Blood Culture Identification (BCID)
The Issue: Increased risk of false positive results for Proteus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec CentriMag Motor
The Issue: Reports of circulatory support system motor stopping. Motor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuro Omega System
The Issue: If cables are improperly connected, current may reach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vereos PET/CT
The Issue: Software Correction: Software errors that may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P...
The Issue: Small hole at the end of the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colpo-Pneumo Occluder
The Issue: The seal of the sterile pouch may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of
The Issue: When multiple CARESCAPEMonitor B450 or B850 units are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of
The Issue: When multiple CARESCAPEMonitor B450 or B850 units are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica HistoCore SPECTRA CV Coverslipper
The Issue: Product was assembled with an isolating fiberglass hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemotherm 400CE
The Issue: for membrane (control panel) switch errors leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Retractor System Elastic Stays (Part 3314-lG
The Issue: There is a possibility that the seal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.