Katalyst Surgical, Llc: Forceps, Ophthalmic
Recall Summary Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps (27ga DEX Stiff Super Grip Forceps, Model DVF4034-27), which are sterile surgical instruments used to grasp and manipulate eye tissues during eye surgery. The recall affects products distributed nationwide in the U.S. and internationally in Peru, Argentina, South Korea, Japan, and France. The FDA has classified this as a Class I recall, indicating a serious issue, though the specific reason for the recall is not detailed in the provided information.
- Recalling firm
- Katalyst Surgical, LLC
- Product
- DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
- Reason
- Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
- 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/b7b6b95a-211d-4c48-bff8-30cf40b9ef90