Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator

Lack of sterility assurance.

A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" notification dated 5/23/25 was mailed to consignees. The notification instructs customers to identify affected devices in inventory and immediately place them in quarantine. The provided Acknowledgement Form is to be completed and returned via email to FCA1@integralife.com or FAX at 1-609-750-4220. Customers are to keep a copy of the notification for their records and forward a copy to users. A Returned Materials Authorization number and instructions to return product will be provided by Customer Service upon receipt of the completed Acknowledgement Form. The notification instructs sales representatives and distributors to identify affected devices in inventory and immediately place them in quarantine. The provided Acknowledgement Form is to be completed and returned via email to FCA1@integralife.com or FAX at 1-609-750-4220. These individuals are instructed to keep a copy of the notification for their records and to forward the notice to individuals who received distributed product. Distributors are to collect response forms from their customers and provide them to Integra to obtain a Returned Materials Authorization number and directions to return product. Sales representatives will be contacted by Post Market Quality to provide recall instructions. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.

• FDA enforcement recordOfficial FDA database entry for Z-1961-2025
• FDA 510(k) clearance · K082454The device's official FDA premarket clearance record
• FDA device classification · FMFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.