Class II U.S. Food and Drug Administration

Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance

Recall published 9 months ago

Devices which did not undergo thermoforming could deform and lose performance.

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: Devices which did not undergo thermoforming could deform and lose performance.

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-1289-2026
Published
February 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Olympus Corporation of the Americas
Product type
Medical devices
Units affected
1490 units (OUS only)
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog Number: KD-401Q-0730; Material REF: 5857030; UDI-DI: 04953170041709; All Lots with a valid expiration date
UPC codes
04953170041709

Products covered by this recall

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Check your product

The notice names 3 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.

  • 04953170041709

Model or item number

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

  • KD-401Q-0730
  • 5857030

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

Olympus Corporation of the Americas — 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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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: Olympus Corporation of the Americas — 3500 Corporate Pkwy, Center Valley, PA, 18034-8229

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 Olympus Corporation of the Americas medical devices recalled?

Devices which did not undergo thermoforming could deform and lose performance. Devices which did not undergo thermoforming could deform and lose performance.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04953170041709; model number KD-401Q-0730, 5857030. 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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