FDA Enforcement
Class II
Ongoing
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Recall: Z-2069-2026
·
Reported May 13, 2026
Enforcement
- Recall Number
- Z-2069-2026
- Event ID
- 98660
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Katalyst Surgical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2026
- Initiation Date
- March 25, 2026
- Classification Date
- May 6, 2026
- Address
- 722 Goddard Ave, Chesterfield, MO, 63005-1100, United States
Description
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Reason
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Code Info
Lot Code: Model No: DVF4005-23 UDI-DI: (01)10817489021658(11)250924(17)280924(10)M50529 Lot Number: M50529 Expiration Date: 09/04/2028
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Quantity
5 units