← FDA ENFORCEMENT
Z-2076-2026Class 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
150 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, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

Code / lot info

Lot Code: Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251017(17)281017(10)M50931 Lot Number: M50931 Expiration Date: 10/17/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251209(17)281209(10)M51130 Lot Number: M51130 Expiration Date: 12/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260115(17)290115(10)M51589 Lot Number: M51589 Expiration Date: 01/15/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260205(17)290205(10)M52018 Lot Number: M52018 Expiration Date: 02/05/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260220(17)290220(10)M52195 Lot Number: M52195 Expiration Date: 2/20/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50073 Lot Number: M50073 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50287 Lot Number: M50287 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251007(17)281007(10)M50677 Lot Number: M50677 Expiration Date: 10/07/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251103(17)281103(0)M50991 Lot Number: M50991 Expiration Date: 11/03/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251113(17)281113(10)M51071 Lot Number: M51071 Expiration Date: 11/13/2028

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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.