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Recall Observatory FDA recall evidence

Device product

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

Z-2071-2026

March 25, 2026

Class II

Product summary

Firm
Katalyst Surgical, LLC
Event
Event 98660
Status
Ongoing
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-2071-2026

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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