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Recall

Class II — Katalyst Surgical, LLC

Recalling firmKatalyst Surgical, LLC
Registered facilityKATALYST SURGICAL, LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonField Safety Corrective Action for IFU in DEX Forceps and Scissors.
ProductDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Quantity235 units
DistributionWorldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Initiated2026-03-25
Classified2026-05-06
Recall numberZ-2077-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Katalyst Surgical, LLC (Z-2077-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98660/

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