Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow S…

Recall date

May 23, 2025

Source

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

Recall number

Z-1961-2025

FDA classification

Class I

Brand / firm

Integra LifeSciences Corp. (NeuroSciences)

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland…

Why it was recalled

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

MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.