← FDA ENFORCEMENT
Z-2071-2026Class 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
80 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 Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

Code / lot info

Lot Code: Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250909(17)280909(10)M49277 Lot Number: M49277 Expiration Date: 09/09/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250513(17)280513(10)M47588, Lot Number: M47588 Expiration Date: 05/13/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47364, Lot Number: M47364 Expiration Date: 05/06/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47363 Lot Number: M47363 Expiration Date: 05/06/2028

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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.