FDA Device recall Z-1953-2025
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No softwar…
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No softwar… by Tecfen Medical, citing sterility assurance for Ophthalmic knives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1953-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-25 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tecfen Medical |
| Distribution | US |
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
Sterility assurance for Ophthalmic knives.
Identifiers
| code_info | Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY23062808-02 UDI: 00817618021422 |
|---|
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-1953-2025%22
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