# FDA recall Z-1961-2025

> **Integra LifeSciences Corp. (NeuroSciences)** · Class I · device recall initiated 2025-05-23.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1961-2025
- **Recalling firm:** Integra LifeSciences Corp. (NeuroSciences)
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-23
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2025

## Citation

> AI Analytics. FDA recall Z-1961-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1961-2025. Source: US FDA. Licensed CC0.

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