Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM, Box of 1.

Recall date

May 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1960-2025

FDA classification

Class I

Brand / firm

Integra LifeSciences Corp. (NeuroSciences)

Sold / distributed

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From B…

Why it was recalled

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Extended Tip Applicator 8CM, Box of 1.