Device recall

Z-1950-2025: Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog…

FDA device recall · Class II · Tecfen Medical

Key facts

Recall number (Z-number) Z-1950-2025
Recall event 96872
Product Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create…
Product code HNN
Recalling firm Tecfen Medical
Recall class Class II
Status Open, Classified
FEI number 3010487482

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)