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# Integra Recalls MicroMyst Applicators
- URL: https://www.fdaweb.com/integra-recalls-micromyst-applicators/
- Published: 2025-07-21T12:00:00.000Z
- Updated: 2026-09-14T15:17:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159541

Integra LifeSciences is recalling (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were adequately sterilized. “The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/applicator-recall-integra-lifesciences-removes-micromyst-applicators-due-potential-sterility?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. To date, Integra LifeSciences says it has not received any reports of serious injuries or deaths associated with the issue.

The company says the device is intended for use in the delivery of the two DuraSeal precursor solutions, which is the company’s product used as an adjunct to sutured dural repair, onto a surgical site at the same time.