Recall Z-1961-2025— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1961-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-23

Class I · Ongoing

Class I FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-05-23. It names one FDA 510(k) clearance: K082454. 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: Lack of sterility assurance..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class I
Status: Ongoing
Initiated: 2025-05-23
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K082454 — MICROMYST APPLICATOR, MODEL 20-5000Covidien·cleared 2008-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.