Class II FDA device recall · Z-2080-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

Why it was recalled

Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29/2028  Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)250527(17)280527(10)M48044 Lot Number: M48044 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48163 Lot Number: M48163 Expiration Date: 06/10/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47612 Lot Number: M47612 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250617(17)280617(10)M48071 Lot Number: M48071 Expiration Date: 06/17/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48164 Lot Number: M48164 Expiration Date: 06/10/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48470 Lot Number: M48470 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48471 Lot Number: M48471 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48657 Lot Number: M48657 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250807(17)280807(10)M49169 Lot Number: M49169 Expiration Date: 08/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250806(17)280806(10)M49170 Lot Number: M49170 Expiration Date: 08/06/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250819(17)280819(10)M49287 Lot Number: M49287 Expiration Date: 08/19/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49777 Lot Number: M49777 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49776 Lot Number: M49776 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49830 Lot Number: M49830 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49831 Lot Number: M49831 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49907 Lot Number: M49907 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250904(17)280904(10)M49906 Lot Number: M49906 Expiration Date: 09/04/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49925 Lot Number: M49925 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49926 Lot Number: M49926 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50538 Lot Number: M50538 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50628 Lot Number: M50628 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50629 Lot Number: M50629 Expiration Date: 10/03/2028  Model No:DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50897 Lot Number: M50897 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50898 Lot Number: M50898 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251007(17)281007(10)M50678 Lot Number: M50678 Expiration Date: 10/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251015(17)281015(10)M50917 Lot Number: M50917 Expiration Date: 10/15/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251017(17)281017(10)M50932 Lot Number: M50932 Expiration Date: 10/17/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251107(17)281107(10)M50993 Lot Number: M50993 Expiration Date: 11/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251113(17)281113(10)M51034 Lot Number: M51034 Expiration Date: 11/13/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51076 Lot Number: M51076 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51077 Lot Number: M51077 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51131 Lot Number: M51131 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51235 Lot Number: M51235 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51236 Lot Number: M51236 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251218(17)281218(10)M51292 Lot Number: M51292 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)251218(17)281218(10)M51293 Lot Number: M51293 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)10718489025557(11)260107(17)290107(10)M51329 Lot Number: 51329 Expiration Date: 01/07/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51630 Lot Number: M51630 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51629 Lot Number: M51629 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51699 Lot Number: M51699 Expiration Date: 01/20/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51700 Lot Number: M51700 Expiration Date: 01/20/2029

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: Katalyst Surgical, LLC
Product type: Devices
Recall number: Z-2080-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Chesterfield, MO
Recall initiated: 2026-03-25

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2080-2026 · Source: openFDA enforcement.