MicroMyst Applicator — Class I medical device recall Z-1961-2025
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-07-02, distributed nationwide. Lack of sterility assurance.
| Recall number | Z-1961-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-05-23 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CN, DE, ES, FR, GB, IE, IL, IT, KE, KR, NZ, PE, SE, SI, SV, TT, TW, VN, ZA |
| Quantity | 4,882 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780000112 |
| Model numbers | 205000DS |
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 for recall
Lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1961-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.