Z-1961-2025Class I

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

Name: Z-1961-2025 MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-05-23
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-05-23 / Open, Classified / root cause: sterility

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of 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... on 2025-05-23. FDA classified it as Class I and gives the reason as "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1961-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-06-20
Recalling firm: Integra LifeSciences Corporation
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.
Product code: FMF Syringe, Piston
Reason for recall: Lack of sterility assurance.
Root cause tag: sterility
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 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, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
Product codes and lots: Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1961-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1961-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20

Product code FMF

K082454Class IIMicromyst Applicator, Model 20-5000Covidien / cleared 2008-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)