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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-2074-2026
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
670 units
Distribution
Nationwide
Made in
United States
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: …
UPC codes
10817489022143, 10840096205135

Products covered by this recall

DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

Check your product

The notice names 20 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.

  • 10817489022143
  • 10840096205135

Best-by / use-by date

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

  • 09
  • 04
  • 17
  • 24
  • 10
  • 03
  • 07
  • 08
  • 15
  • 21
  • 29
  • 11
  • 13
  • 12
  • 06
  • 19
  • 26

Model or item number

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

  • DVF4019-25 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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 10817489022143, 10840096205135; best-by date 09 or 04; model number DVF4019-25 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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