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 11461–11480 of 38,428 recalls
Recalled Item: Wireless Footswtich used with the following Philips Allura Xper and
The Issue: Wireless foot switch connection issues causing interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System:...
The Issue: The Instructions for Use have been updated to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray...
The Issue: It was noticed in production on 28.10.2021, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Assemblies
The Issue: This recall has been initiated to address bulk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF
The Issue: Due to consoles not in compliance with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVLP Convenience Pack/Kit
The Issue: NaCl 250 mL Bag Inj expired 04/2020 while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venous Access Pack-LF Convenience Kit
The Issue: NaCl 250 mL Bag Inj expired 04/2020 while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Major Vascular CDS Convenience Kit
The Issue: NaCl 250 mL Bag Inj expired 04/2020 while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bedside PICC CDS Convenience Kit
The Issue: NaCl 250 mL Bag Inj expired 04/2020 while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuro Convenience Kit
The Issue: NaCl 250 mL Bag Inj expired 04/2020 while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is a handheld ultraviolet-C germicidal wand and contains two
The Issue: Excessive ultraviolet-C radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODULIFT VBR SZ.M 4MM SET SCREW DRIVER
The Issue: Set screwdriver fails during surgery by deforming at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter
The Issue: The languages for Russian, Romanian, Slovak, and Czech
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)
The Issue: The labels on the packages of screws were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX Pentra Calcium AS CP
The Issue: Product was shipped from a Medline warehouse to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott HeartMate Touch Communication System
The Issue: If LVAS communication system is trying to establish
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Ocean Water Seal Chest Drain is a plastic
The Issue: Inadequate/inappropriate Set-Up Instructions, which may result in delay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system
The Issue: If the system experiences an overvoltage / power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system
The Issue: If the system experiences an overvoltage / power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iDesign
The Issue: Aberrometer and precision laser systems are affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.