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Recall Observatory FDA recall evidence

Device 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.

Z-1961-2025

May 23, 2025

Class I

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
Event
Event 96965
Status
Ongoing
Classification
Class I
Quantity
4,882 units
Official record key
device-enforcement:Z-1961-2025

Official wording

Reason: Lack of sterility assurance.

Code information: Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility