Katalyst Surgical, Llc: Forceps, Ophthalmic
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps (surgical instruments used in eye procedures) due to incorrect instructions for use. The recall is classified as Class I, the most serious type, and affects units distributed throughout the United States and internationally in Peru, Argentina, South Korea, Japan, and France. Healthcare facilities and users who have these forceps should check if they have affected units.
- Recalling firm
- Katalyst Surgical, LLC
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-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/772053e1-b5ee-42ca-8965-4ba0d0c89c67