Class II U.S. Food and Drug Administration

Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors

Recall published 6 months ago

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2077-2026
Published
May 13, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Katalyst Surgical, LLC
Product type
Medical devices
Units affected
235 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M51041 Lot Number: M51041 Expiration Date: 11/25/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250819(17)280819(10)M50093 Lot Number: M50093 Expiration Date: 08/19/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50293 Lot Number: M50293 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50216 Lot Number: M50216 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251021(17)281021(10)M50431 Lot Number: M50431 Expiration Date: 10/21/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251017(17)281017(10)M50543 Lot Number: M50543 Expiration Date: 10/17/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251023(17)281023(10)M50634 Lot Number: M50634 Expiration Date: 10/23/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251103(17)281103(10)M50903 Lot Number: M50903 Expiration Date: 11/03/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251113(17)281113(10)M50937 Lot Number: M50937 Expiration Date: 11/13/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M50997 Lot Number: M50997 Expiration Date: 11/25/2028
UPC codes
10840096205142

Products covered by this recall

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10840096205142

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 25
  • 08
  • 19
  • 09
  • 24
  • 10
  • 21
  • 17
  • 23
  • 03
  • 13
  • 2028 — 235 units

Model or item number

On the rating label, the box or the instruction sheet.

  • DVF4022-25-S UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Katalyst Surgical, LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Katalyst Surgical, LLC — 722 Goddard Ave, Chesterfield, MO, 63005-1100

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Katalyst Surgical, LLC medical devices recalled?

Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10840096205142; best-by date 11 or 25; model number DVF4022-25-S UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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