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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY23062808-02 UDI: 00817618021422
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Tecfen Medical
Reason for Recall:
Sterility assurance for Ophthalmic knives.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY23062808-02 UDI: 00817618021422

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1953-2025

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