FDA Enforcement Class II Ongoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Recall: Z-2077-2026 · Reported May 13, 2026

Enforcement

Recall Number
Z-2077-2026
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, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Reason

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

Code Info

Lot Code: Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M51041 Lot Number: M51041 Expiration Date: 11/25/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250819(17)280819(10)M50093 Lot Number: M50093 Expiration Date: 08/19/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50293 Lot Number: M50293 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50216 Lot Number: M50216 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251021(17)281021(10)M50431 Lot Number: M50431 Expiration Date: 10/21/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251017(17)281017(10)M50543 Lot Number: M50543 Expiration Date: 10/17/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251023(17)281023(10)M50634 Lot Number: M50634 Expiration Date: 10/23/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251103(17)281103(10)M50903 Lot Number: M50903 Expiration Date: 11/03/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251113(17)281113(10)M50937 Lot Number: M50937 Expiration Date: 11/13/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M50997 Lot Number: M50997 Expiration Date: 11/25/2028

Distribution

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

Quantity

235 units