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 36761–36780 of 38,428 recalls
Recalled Item: Drill Guide - Chameleon FacetFuse Fixation System
The Issue: Prior to use in surgery, the Drill Guides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare became aware of a potential issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp).
The Issue: It was reported that the number scale/graduation markings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SynchroMed EL
The Issue: Medtronic notified Healthcare Professionals of the impact of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II
The Issue: Medtronic notified Healthcare Professionals of the impact of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue Information Center/Client and Philips IntelliVue...
The Issue: Internal audio cable may have diminished retention force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are
The Issue: With regards to ShapeMatch Cutting Guides using MRI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system
The Issue: Lost and incorrect images. When using the "F-Rec"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Angio Drape Pack Radiology-LF
The Issue: The non-sterile Waste Bag component in the custom
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnteraLite Infinity Enteral Feeding Pump identified with the following list
The Issue: MOOG Medical Devices Group is conducting a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code:
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl
The Issue: Polyaxial screws 8x 80 and larger may disassociate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 25-Hydroxy Vitamin D EIA
The Issue: Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.