Extended Tip Applicator 8CM — Class I medical device recall Z-1960-2025
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-07-02, distributed nationwide. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
| Recall number | Z-1960-2025 |
|---|---|
| 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 | 2025-05-22 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, ES, FR, GR, GT, HK, HU, IE, IR, IT, JO, JP, KR, MT, MX, NG, NL, NZ, PA, PE, PT, RO, SA, SE, SG, SV, TR, TW, ZA |
| Quantity | 212 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780000167 |
| Model numbers | 201108 |
Product
Extended Tip Applicator 8CM, Box of 1.
Reason for recall
Devices contain potentially out-of-specification levels of endotoxins and 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-1960-2025. 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.