Class I

Medical Device Recall: 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.

Integra LifeSciences Corp. (NeuroSciences) · May 23, 2025

Reason for Recall

Lack of sterility assurance.

Distribution

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 and United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

4,882 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1961-2025

Status: ongoing

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