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 11021–11040 of 38,428 recalls
Recalled Item: Philips
The Issue: There is a potential for AED pads to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCL1 Breakapart Probe
The Issue: May show unexpected locus specific signals in addition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic TurboHawk Plus Directional Atherectomy System 6F
The Issue: The device has similarities in design to another
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic TurboHawk Plus Directional Atherectomy System 6F
The Issue: The device has similarities in design to another
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Procedure Kit catalog # 76645 & 73806
The Issue: for Cardiovascular Procedure Kit packaging damage that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller)
The Issue: Multi-Modality Touch Screen Modules (MM-TSM), used with integrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity s System software version2.8.0
The Issue: Software error associated with the immunoassay analyzer wash
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips StentBoost Live R2.0 application
The Issue: Due to an incorrect configuration setting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura (Model Numbers 722010
The Issue: Due to a software defect, the Philips StentBoost
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NuOss Collagen Block Size 8mm x 9mm x 9mm- used
The Issue: NuOss Collagen (dental) was packaged with a Collatene
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) JOBST Compri2
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N
The Issue: Malfunction of the hand pendant controlling movement of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.