Reported Jun 18, 2025 · Ongoing
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software…
Tecfen Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tecfen Medical · 6100 Hollister Ave # 3 · Santa Barbara, CA · 93117-3272
Is this the product you have?
- Brand NameTecfen
- Medical Product Name20G (1.2mm) MVR Sideport
- Knife Straight Model/Catalog NumberQKN2312
- Software VersionNo
- software Product DescriptionThis 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
- ComponentNo
- Lot codes and dates
- Lot CodeManufacture
- date2024-11-21
- Expiration date2027-11-20
- Lot numberZGY23062808-02
- UDI00817618021422
- Amount recalled
- 38 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Sterility assurance for Ophthalmic knives.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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