DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

Recall: Z-2076-2026 · Reported May 13, 2026

Enforcement

Recall Number: Z-2076-2026
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

Reason

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

Code Info

Lot Code: Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251017(17)281017(10)M50931 Lot Number: M50931 Expiration Date: 10/17/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251209(17)281209(10)M51130 Lot Number: M51130 Expiration Date: 12/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260115(17)290115(10)M51589 Lot Number: M51589 Expiration Date: 01/15/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260205(17)290205(10)M52018 Lot Number: M52018 Expiration Date: 02/05/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260220(17)290220(10)M52195 Lot Number: M52195 Expiration Date: 2/20/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50073 Lot Number: M50073 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50287 Lot Number: M50287 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251007(17)281007(10)M50677 Lot Number: M50677 Expiration Date: 10/07/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251103(17)281103(0)M50991 Lot Number: M50991 Expiration Date: 11/03/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251113(17)281113(10)M51071 Lot Number: M51071 Expiration Date: 11/13/2028

Distribution

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

Quantity

150 units