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-2078-2026
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
750 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250422(17)280422(10)M47116 Lot Number: M47116 Expiration Date: 04/22/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250610(17)280610(10)M48162 Lot Number: M48162 Expiration Date: 06/10/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250618(17)280618(10)M48276 Lot Number: M48276 Expiration Date: 06/18/2028 Model No: DVF4034-35 UDI-DI: (01)10817489025540(11)250626(17)280626(10)M48303 Lot Number: M48303 Expiration Date: 06/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250730(17)280730(10)M49168 Lot Number: M49168 Expiration Date: 07/30/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250807(17)280807(10)M49270 Lot Number: M49270 Expiration Date: 08/07/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49285 Lot Number: M49285 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49286 Lot Number: M49286 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49775 Lot Number: M49775 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49829 Lot Number: M49829 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250826(17)280826(10)M49905 Lot Number: M49905 Expiration Date: 08/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50289 Lot Number: M50289 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50208 Lot Number: M50208 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250924(17)280924(10)M50290 Lot Number: M50290 Expiration Date: 09/24/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251015(17)281015(10)M50916 Lot Number: M50916 Expiration Date: 10/15/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251020(17)281020(10)M50992 Lot Number: M50992 Expiration Date: 10/20/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251023(17)281023(10)M51033 Lot Number: M51033 Expiration Date: 10/23/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51074 Lot Number: M51074 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51075 Lot Number: M51075 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251113(17)281113(10)M51234 Lot Number: M51234 Expiration Date: 11/13/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251125(17)281125(10)M51290 Lot Number: M51290 Expiration Date: 11/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251126(17)281126(10)M51291 Lot Number: M51291 Expiration Date: 11/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251209(17)281209(10)M51521 Lot Number: M51521 Expiration Date: 12/09/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251218(17)281218(10)M51628 Lot Number: M51628 Expiration Date: 12/18/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260120(17)290120(1)M51698 Lot Number: M51698 Expiration Date: 01/20/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M51893 Lot Number: M51893 Expiration Date: 02/03/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M52019 Lot Number: M52019 Expiration Date: 02/03/2029
UPC codes
10817489025540

Products covered by this recall

DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

Check your product

The notice names 23 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.

  • 10817489025540

Best-by / use-by date

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

  • 04
  • 22
  • 06
  • 10
  • 18
  • 26
  • 07
  • 30
  • 08
  • 19
  • 25
  • 09
  • 17
  • 24
  • 15
  • 20
  • 23
  • 29
  • 11
  • 13

Model or item number

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

  • DVF4034-25 UDI-DI
  • DVF4034-35 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. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

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 10817489025540; best-by date 04 or 22; model number DVF4034-25 UDI-DI, DVF4034-35 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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