Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1954-2025 — 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 creat

U.S. FDA — Device Enforcement · United States · 2025-04-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1954-2025
Date of alert: 2025-04-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Tecfen Medical
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00817618021330

Reported risk: Sterility assurance for Ophthalmic knives.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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