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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-2073-2026
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
50 units
Distribution
Nationwide
Made in
United States
Lot / code 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
UPC codes
10817489022136

Products covered by this recall

DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

Check your product

The notice names 14 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.

  • 10817489022136

Best-by / use-by date

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

  • 08
  • 07
  • 10
  • 17
  • 11
  • 13
  • 12
  • 01
  • 15
  • 09
  • 04
  • 2028 — 50 units

Model or item number

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

  • DVF4019-23 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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 10817489022136; best-by date 08 or 07; model number DVF4019-23 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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