DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

FDA Device Recall #Z-2079-2026 — Class II — March 25, 2026

Recall Summary

Recall Number Z-2079-2026
Classification Class II — Moderate risk
Date Initiated March 25, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Katalyst Surgical, LLC
Location Chesterfield, MO
Product Type Devices
Quantity 50 units

Product Description

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

Reason for Recall

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Distribution Pattern

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

Lot / Code Information

Lot Code: Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)250429(17)280429(10)M47337 Lot Number: M47337 Expiration Date: 04/29/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251023(17)281023(10)M50921 Lot Number: M50921 Expiration Date: 10/23/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251209(17)281209(10)M51525 Lot Number: M51525 Expiration Date: 12/09/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251209(17)281209(10)M51526 Lot Number: M51526 Expiration Date: 12/09/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)260220(17)290220(10)M52172 Lot Number: M52172 Expiration Date: 02/20/2029

Other Recalls from Katalyst Surgical, LLC

Recall # Classification Product Date
Z-2070-2026 Class II DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Ta... Mar 25, 2026
Z-2073-2026 Class II DEX Ophthalmic Tissue Forceps, 23ga DEX Maculor... Mar 25, 2026
Z-2071-2026 Class II DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff A... Mar 25, 2026
Z-2074-2026 Class II DEX Ophthalmic Tissue Forceps, 25ga DEX Maculor... Mar 25, 2026
Z-2069-2026 Class II DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTap... Mar 25, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.