DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Summary
The FDA issued a Class II for DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalo by Katalyst Surgical, LLC. Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors..
Details
Source
Device Recall
External ID
Z-2076-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Lot/Code 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
Quantity Affected: 150 units
Reason for Recall
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Chesterfield, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Katalyst Surgical, LLC has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Katalyst Surgical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Katalyst Surgical, LLC have FDA actions?
Katalyst Surgical, LLC has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2076-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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