FDA Device recall Z-1961-2025
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the contro…
- FDA Device
- Class I
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class I recall of MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the contro… by Integra Lifesciences Neurosciences, citing lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1961-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
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.
Reason
Lack of sterility assurance.
Identifiers
| code_info | Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2025%22
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