Z-1961-2025 Class I Ongoing
FDA device recall Z-1961-2025 was initiated by Integra LifeSciences Corp. (NeuroSciences) on May 23, 2025 and is designated Class I. Reason for recall: Lack of sterility assurance. The recall status is ongoing. Affected quantity: 4,882 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,882 units
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.
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
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.
Code Information
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.