Reported Jun 18, 2025 · Ongoing
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No…
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 Name2.4mm Slit Knife
- Angled Model/Catalog NumberQKN2461
- Software VersionNo
- software Product DescriptionThis is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye
- ComponentNo
- Lot codes and dates
- Lot CodeManufacture
- date2024-11-21
- Expiration date2027-11-20
- Lot numberZGY24081907-02
- UDI00817618021156
- Amount recalled
- 115 unit
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.
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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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