Katalyst Surgical, Llc: Forceps, Ophthalmic

Recall Summary Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps and DEX Stiff End Grasping Forceps used in eye surgery due to incorrect instructions for use. The affected forceps were distributed nationwide in the US as well as in Peru, Argentina, South Korea, Japan, and France. This is classified as a Class I recall, the most serious category.

Recalling firm
Katalyst Surgical, LLC
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-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/0574dfec-a6a2-4953-94c3-1e672a535047