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U.S. Department of Health and Human Services

Class 1 Device Recall MicroMyst Applicator

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 Class 1 Device Recall MicroMyst Applicatorsee related information
Date Initiated by FirmMay 23, 2025
Date PostedJune 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1961-2025
Recall Event ID 96965
510(K)NumberK082454 
Product Classification Syringe, piston - Product Code FMF
ProductMicroMyst 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.
Code Information Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactMary O'Neill
1-640-8679411
Manufacturer Reason
for Recall		Lack of sterility assurance.
FDA Determined
Cause 2		Process change control
ActionA "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.
Quantity in Commerce4,882 units
DistributionWorldwide 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, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMF
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