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 22221–22240 of 38,428 recalls
Recalled Item: ESSENTIO MRI SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO MRI EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALITUDE X4 CRT-P Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VISIONIST X4 CRT-P Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT VDD SL Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUA 2 DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO MRI DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT MRI Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Health Harmony Mobile application software Product Usage: Care Innovations...
The Issue: It was discovered that in certain situations, including
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Suspension Arm (P/N: 525004
The Issue: Product has been found with a missing Washer,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device
The Issue: Medtronic has discovered the directional arrow at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: An accessory (range shifter, ridge filter&) can be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the
The Issue: A software malfunction was found where WBC, RBC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem VELOCITY Urine Chemistry Strips
The Issue: A subset of Lot 7212154 A of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Truth Renew
The Issue: Distribution of medical devices with unapproved green LED
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncomine Dx Target Test User Guides and Assay Definition File
The Issue: The Oncomine Dx Target Test may report erroneous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonimage HS1 Ultrasound Kit AC adapter
The Issue: There is a risk of circuit board breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonimage HS1 Ultrasound Kit AC adapter
The Issue: There is a risk of circuit board breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.