Recall Z-1953-2025— Tecfen Medical
Class II · Ongoing
Class II FDA medical device recall by Tecfen Medical, initiated 2025-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Tecfen Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-25
- Firm location
- Santa Barbara, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.