DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019...
FDA Device Recall #Z-2075-2026 — Class II — March 25, 2026
Recall Summary
| Recall Number | Z-2075-2026 |
| 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 | 645 units |
Product Description
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-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: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M47123 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250429(17)280429(10)M47336 Lot Number: M47336 Expiration Date: 04/29/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250618(17)280618(10)M48308 Lot Number: M48308 Expiration Date: 06/18/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250709(17)280709(10)M48660 Lot Number: M48660 Expiration Date: 07/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250807(17)280807(10)M49294 Lot Number: M49294 Expiration Date: 08/07/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250819(17)280819(10)M49784 Lot Number: M49784 Expiration Date: 08/19/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49839 Lot Number: M49839 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49910 Lot Number: M49910 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250904(17)280904(0)M49929 Lot Number: M49929 Expiration Date: 09/04/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250909)17)280909(10)M49930 Lot Number: M49930 Expiration Date: 09/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250917(17)280917(10)M50215 Lot Number: M50215 Expiration Date: 09/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50427 Lot Number: M50427 Expiration Date: 09/24/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50429 Lot Number: M50429 Expiration Date: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50428 Lot Number: M50428 Expiration Date: 09/24/2028
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.