FDA recall Z-2080-2026

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Key facts

Status

Ongoing

Initiation date

2026-03-25

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesterfield, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2080-2026