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 16081–16100 of 38,428 recalls
Recalled Item: Arrow Maximal Barrier Drape ASK-00002-1A
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EPIDURAL CATHETERIZATION KIT AM-05500
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow SPINAL ANESTHESIA SET ASA-25090-S
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EPIDURAL NEEDLE KIT SL-05500
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EPIDURAL NEEDLE COMPONENT AN-05505
The Issue: Product lidstock contains the incorrect expiration date for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Healthcare Systems
The Issue: A component (1961 TELFA PAD 2 X 3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ARTIS pheno
The Issue: The potential exists for system movement to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received
The Issue: Monitor/Defibrillator may not deliver a shock after the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
The Issue: Monitor/Defibrillator may not deliver a shock after the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAINLESS STEEL REPROCESSING TRAY
The Issue: Small but detectable holes in the sterilization wrap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAINLESS STEEL REPROCESSING TRAY
The Issue: Small but detectable holes in the sterilization wrap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
The Issue: LEGION PS High Flex XLPE Articular Insert was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Daytona Plus (with ISE/without ISE)
The Issue: Software version UI2550642107 for the RX Daytona +
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost GCF
The Issue: When using the Table Up/Down button, the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost PCF
The Issue: When using the Table Up/Down button, the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation stand-alone software treatment planning system. Models 4.0
The Issue: Three issues found: i) The Map ROI options
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp
The Issue: issue associated with the instrument -end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: There have been reports of excessive heating in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.