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 8161–8180 of 38,428 recalls
Recalled Item: TRACKMASTER
The Issue: Treadmill malfunction: drive PCB can misread the signals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRACKMASTER
The Issue: Treadmill malfunction: drive PCB can misread the signals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Icelock 125 Ratchet
The Issue: A mechanical lock used to connect and release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Driver Instrument
The Issue: Pending update to indirect decompression system instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP software of the Ivenix Infusion System (IIS)
The Issue: Retroactively reported corrections from 2023: 1) A software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist
The Issue: When multiple processes are running on the watch's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist
The Issue: When multiple processes are running on the watch's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBB2D4 VIVA S IS1/DF4 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD CROME HF MRI IS1 DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMA2D1 CLARIA MRI OUS DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMC1D1 COMPIA MRI US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMB1D4 AMPLIA MRI US DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR VISIA AF S US/OUS IS1/DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD COBALT XT HF QUAD OUS
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.