FDA-Device2025-07-02Class I
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.
Hazard
Lack of sterility assurance.
Sold states
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.
Affected count
4,882 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2025More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-05-20Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief