[pending] Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number
Pending LLM rewrite. Source: FDA_DEVICE Z-1954-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Sterility assurance for Ophthalmic knives.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
- Manufacturer
- Tecfen Medical
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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