# FDA recall Z-1953-2025

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

## 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 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-1953-2025
- **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-1953-2025

## Citation

> AI Analytics. FDA recall Z-1953-2025. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-1953-2025. Source: US FDA. Licensed CC0.

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