← FDA ENFORCEMENT
Z-2069-2026Class 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
5 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, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

Code / lot 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

Other recalls SPEQ maps to Risk Management & CAPA
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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.