Katalyst Surgical, Llc: Forceps, Ophthalmic
Recall Summary Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps and DEX Nano Tapered AWH Forceps used in eye surgery due to incorrect instructions for use. The recall is classified as Class I, the most serious type, and affects products distributed nationwide in the US as well as in Peru, Argentina, South Korea, Japan, and France. Healthcare facilities and surgical centers that have received these forceps should check their inventory against the specific model numbers provided.
- Recalling firm
- Katalyst Surgical, LLC
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
- 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/ed83d47b-9dfa-4d4a-8573-553f9535a0b0