FDA Medical devices recall ·
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model recall
- Recall number
- Z-2080-2026
- Date
- (initiated March 25, 2026)
- Company / brand
- Katalyst Surgical, LLC
722 Goddard Ave, Chesterfield, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1330 units
- Hazard tags
- Sterility Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29/2028 Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)250527(17)280527(10)M48044 Lot Number: M48044 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48163 Lot Number: M48163 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47612 Lot Number: M47612 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250617(17)280617(10)M48071 Lot Number: M48071 Expiration Date: 06/17/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48164 Lot Number: M48164 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48470 Lot Number: M48470 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48471 Lot Number: M48471 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028 M
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2080-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.