Katalyst Surgical, Llc: Forceps, Ophthalmic

Recall Summary Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps and 25ga DEX Stiff Asymmetrical Tano Forceps due to incorrect instructions for use. The recall affects these surgical forceps distributed nationwide in the US and in Peru, Argentina, South Korea, Japan, and France. This is a Class I recall, the most serious classification.

Recalling firm

Katalyst Surgical, LLC

Product

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

Reason

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Classification

Class I

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-03-25

Status

Open, Classified

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f87821ee-2d91-458f-86e7-5b4bb62f7d53