← FDA ENFORCEMENT
Z-2073-2026Class 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
50 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 Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

Code / lot info

Lot Code: Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250807(17)280807(10)M49267 Lot Number: M49267 Expiration Date: 08/07/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251017(17)281017(10)M50930 Lot Number: M50930 Expiration Date: 10/17/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251113(17)281113(10)M51230 Lot Number: M51230 Expiration Date: 11/13/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251212(17)281212(10)M51587 Lot Number: M51587 Expiration Date: 12/12/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)260115(17)290115(10)M51696 Lot Number: M51696 Expiration Date: 01/15/2029 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250904(17)280904(10)M49921 Lot Number: M49921 Expiration Date: 09/04/2028 Model No; DVF4019-23 UDI-DI: (01)10817489022136(11)251107(17)281107(10)M51128 Lot Number: M51128 Expiration Date: 11/07/2028

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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.