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 35181–35200 of 38,428 recalls
Recalled Item: Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Plus Monitor System (Kit w/10 Count Vials International)
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (10 Count Vials) Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical
The Issue: Medtronic Navigation, Inc. has initiated a field correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Plus Monitor System (Kit w/10 Count Vials Canada)
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (50 Count DME) Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (50 Count Retail) Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 x 93 US Probe Cover CMS-6049
The Issue: No endotoxin (LAL) testing to proper level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta VXT Vascular Grafts >or= 6mm Intended for use in
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SST Bifurcated Grafts >or= 6mm Intended for use in
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flixene IFG with Assisted Delivery Intended for use in arterial
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.