Brand Name: Tecfen Medical Product Name: 3 — Class II medical device recall Z-1955-2025
Ongoing recall by Tecfen Medical, reported 2025-06-18, distributed nationwide. Sterility assurance for Ophthalmic knives.
| Recall number | Z-1955-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecfen Medical, Santa Barbara, CA, United States |
| Recall initiated | 2025-04-25 |
| Classified | 2025-06-11 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BR, CL, DO, HN, IL, IR, MX, QA, SA, ZA |
| Quantity | 26 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00817618021224 |
| Lot numbers | ZGY24022804-05 |
| Model numbers | QKN3261 |
| Expiration dates | 2027-11-20 |
Product
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Reason for recall
Sterility assurance for Ophthalmic knives.
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-1955-2025. 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.