DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Summary
The FDA issued a Class II for DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Numb by Katalyst Surgical, LLC. Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors..
Details
Source
Device Recall
External ID
Z-2074-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Lot/Code Info: Lot Code: Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50065 Lot Number: M50065 Expiration Date: 09/04/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50068 Lot Number: M50068 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50069 Lot Number: M50069 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50070 Lot Number: M50070 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250917(17)280917(10)M50071 Lot Number: M50071 Expiration Date: 09/17/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50422 Lot Number: M50422 Expiration Date: 09/24/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50423 Lot Number: M50423 Expiration Date: 09/24/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50534 Lot Number: M50534 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50536 Lot Number: M50536 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50626 Lot Number: M50626 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251007(17)281007(10)M50625 Lot Number: M50625 Expiration Date: 10/07/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251008(17)281008(10)M50676 Lot Number: M50676 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50895 Lot Number: M50895 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50896 Lot Number: M50896 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50675 Lot Number: M50675 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251015(17)281015(10)M50914 Lot Number: M50914 Expiration Date: 10/15/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251021(17)281021(10)M51032 Lot Number: M51032 Expiration Date: 10/21/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251029(17)281029(10)M51070 Lot Number: M51070 Expiration Date: 10/29/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251107(17)281107(10)M51129 Lot Number: M51129 Expiration Date: 11/07/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251113(17)281113(10)M51231 Lot Number: M51231 Expiration Date: 11/13/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251209(17)281209(10)M51326 Lot Number: M51326 Expiration Date: 12/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251212(17)281212(10)M51588 Lot Number: M51588 Expiration Date: 12/12/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49164 Lot Number: M49164 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49268 Lot Number: M49268 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49269 Lot Number: M49269 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49773 Lot Number: M49773 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49772 Lot Number: M49772 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250826(17)280826(10)M49922 Lot Number: M49922 Expiration Date: 08/26/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50067 Lot Number: M50067 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50066 Lot Number: M50066 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250917(17)280917(10)M50072 Lot Number: M50072 Expiration Date: 09/17/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50421 Lot Number: M50421 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50420 Lot Number: M50420 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50533 Lot Number: M50533 Expiration Date: 10/03/2028 Model No; DVF4019-25 UDI-DI: (01)10840096202608(11)251007(17)281007(10)M50535 Lot Number: M50631 Expiration Date: 10/07/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)28094(10)M49923 Lot Number: M49923 Expiration Date: 09/04/2028
Quantity Affected: 670 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-2074-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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