The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1296-2026·Announced 2026-02-11

Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step

Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record's stated consequence is device deformation and loss of performance, with no patient harm or reported injury.

Plain-English summary

The Single Use 3-Lumen Sphincterotome V, model/catalog number KD-V411M-3025, is being recalled by Olympus Corporation of the Americas. The record describes the instruments as designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

The reason given in the enforcement record is that devices which did not undergo thermoforming could deform and lose performance.

The record lists 1,025 units, and states these are outside the United States only, under material REF N1090210, with the UDI-DI field recorded as N/A, covering all lots with a valid expiration date. Distribution is given as worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The stated consequence in the enforcement record is deformation and loss of performance, and no injuries are reported. Facilities should follow Olympus' instructions.

The recalled product

Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy accessory
Hazard
Affected units
1,025

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model/Catalog Number: KD-V411M-3025
  • Material REF: N1090210
  • UDI-DI: N/A
  • All Lots with a valid expiration date

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

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