# FDA recall Z-1954-2025

> **Tecfen Medical** · Class II · device recall initiated 2025-04-25.

## 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 knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy.  Component: No

## Reason for recall

Sterility assurance for Ophthalmic knives.

## Distribution

Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar,  Iran, and Bangladesh, Brazil and Israel.

## Key facts

- **Recall number:** Z-1954-2025
- **Recalling firm:** Tecfen Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-25
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Barbara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1954-2025

## Citation

> AI Analytics. FDA recall Z-1954-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1954-2025. Source: US FDA. Licensed CC0.

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