MicroMyst Applicator, Box of 5. Consisting of a multilumen… recallZ-1961-2025 · Integra LifeSciences Corp. (NeuroSciences) · initiated May 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lack of sterility assurance.
FDA root cause category: Process change control
What the company is doing
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 [email protected] 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 [email protected] 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.
Recall details
- Recall number
- Z-1961-2025
- Status
- Open, Classified
- Initiated by the company
- May 23, 2025
- Posted by the FDA
- Jun 20, 2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 4,882 units
- Product code
- FMF
- FDA submissions
- K082454
- 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, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
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.
Code information (models, lots, serial numbers)
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MicroMyst 205000DSIntegra Lifesciences Corporation · Syringe, Piston1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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