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 7761–7780 of 38,428 recalls
Recalled Item: MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during...
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-X Rover Mobile X-ray System
The Issue: Shots were terminated by the mAs integrator; however,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trexo Device
The Issue: Electrical issues that could potentially render the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UFSK Treatment chair 500 XLE- Treatment chair for positioning and
The Issue: Service life of the electrical seat part drive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Screws for osteotomies have contain an undersize screwhead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Screws for osteotomies have contain an undersize screwhead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER DxH Diluent
The Issue: Specific diluent lot numbers showed that conductivity, osmolality,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Haemophilus Test Medium (Agar) (150mm)
The Issue: The test medium may not perform as intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Resurfacing Cup - (xx)MM
The Issue: Medical device components were marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACETABULAR FIXATION CUP
The Issue: Medical device components were marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020
The Issue: Medical device components were marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity ci-series System Control Module
The Issue: There are potential performance issues found in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs
The Issue: Weld protrusion/physical gap between the housing and pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Vivid S60N
The Issue: GE HealthCare has become aware that certain Vivid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Vivid S70N
The Issue: GE HealthCare has become aware that certain Vivid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Vivid S70
The Issue: GE HealthCare has become aware that certain Vivid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Vivid S60
The Issue: GE HealthCare has become aware that certain Vivid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD
The Issue: The outer package seal could be open, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.