← FDA ENFORCEMENT
Z-2079-2026Class II

Katalyst Surgical, LLC

Recalling firm
Katalyst Surgical, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Firm state
MO
Product quantity
50 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.