Recall Z-2080-2026— Katalyst Surgical, LLC
Class II · Ongoing
Class II FDA medical device recall by Katalyst Surgical, LLC, initiated 2026-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Katalyst Surgical, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Chesterfield, MO, United States
Product description
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.