MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So

FDA device recall Z-1961-2025 · posted 2025-06-20 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp. (NeuroSciences)

Reason for recall

Lack of sterility assurance.

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

FMF

Quantity affected

4,882 units

Distribution

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,

Date initiated

2025-05-23

Date posted

2025-06-20

Location

Princeton, NJ

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