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 13581–13600 of 38,428 recalls
Recalled Item: Vis-U-All High Temperature Tubing 9"x100'. One roll per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temperature Tubing 6"x100'. One roll per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time
The Issue: Misinterpretation of Displayed Measuring Units from INR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS Prof (Professional) Meters- IVD professional healthcare...
The Issue: Misinterpretation of Displayed Measuring Units from INR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temperature Tubing 3"x100'. One roll per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temperature Tubing 4"x100'. One roll per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos MIC Panel Type 34 - Product Usage: For
The Issue: Due to a customer report and internal investigation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm
The Issue: The rotating luer fitting at the distal end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.