Brand Name: Tecfen Medical Product Name: 20G — Class II medical device recall Z-1953-2025
Ongoing recall by Tecfen Medical, reported 2025-06-18, distributed nationwide. Sterility assurance for Ophthalmic knives.
| Recall number | Z-1953-2025 |
|---|---|
| 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 | 38 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00817618021422 |
| Lot numbers | ZGY23062808-02 |
| Model numbers | QKN2312 |
| Expiration dates | 2027-11-20 |
Product
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. 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-1953-2025. 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.