MicroMyst Applicator (Integra) – Sterility Concern (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Integra LifeSciences Corp. (NeuroSciences)
Lot Codes / Batch Numbers
Model/Catalog Number: 205000DS, UDI No. 10381780000112, All lots.
Products Sold
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Integra LifeSciences Corp. (NeuroSciences) is recalling MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with due to Lack of sterility assurance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026