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 27781–27800 of 38,428 recalls
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the
The Issue: Wrong quantitative results may be displayed in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605)
The Issue: Product may lead to false susceptible results of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebound Air Walker Product Usage: Rebound Air Walkers are indicated
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unloader Custom Lite Product Usage: Unloader Custom Lite is an
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebound Cartilage Product Usage: Rebound Cartilage is an external knee
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unloader XT Product Usage: Unloader XT Extreme is an external
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMCO brand Conforming Stretch Gauze Bandages
The Issue: Product does not meet sterility requirements based on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extreme Custom Product Usage: Extreme Custom is an external knee
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miami J Collar Product Usage: Miami J collars are applied
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.