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FDA recall, , Moderate risk

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.

Summary by Recall Canary from the FDA notice

What happened

Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, recalled Single Use 3-Lumen Sphincterotome V and Disposable Triple Lumen Sphincterotome devices because devices which did not undergo thermoforming could deform and lose performance. The recall began January 7, 2026, and was added to the FDA's Enforcement Report on February 5, 2026. Distribution included US nationwide and international.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Single Use 3-Lumen Sphincterotome V

    Lot code
    All Lots with a valid expiration date
    1. UDI-DI
      • 04953170380563
      Model/Catalog number
      • KD-V411M-0330
    2. UDI-DI
      • 04953170380600
      Model/Catalog number
      • KD-V411M-1520
    3. UDI-DI
      • 04953170380587
      Model/Catalog number
      • KD-V411M-0725
    4. Model/Catalog number
      • KD-V411M-3025
    5. UDI-DI
      • 04953170184178
      Model/Catalog number
      • KD-V431M-0720
    6. UDI-DI
      • 04953170380594
      Model/Catalog number
      • KD-V411M-0730
    7. UDI-DI
      • 04953170380648
      Model/Catalog number
      • KD-V431M-0730
    8. UDI-DI
      • 04953170184154
      Model/Catalog number
      • KD-V411M-3030
    9. Model/Catalog number
      • KD-V411M-3020
    10. UDI-DI
      • 04953170380617
      Model/Catalog number
      • KD-V411M-1530
    11. UDI-DI
      • 04953170184017
      • 04953170380570
      Model/Catalog number
      • KD-V411M-0720

    Some entries omit identifying details. Check the notice to confirm which units are affected.

  2. Disposable Triple Lumen Sphincterotome

    Lot code
    All Lots with a valid expiration date
    1. UDI-DI
      • 04953170041617
      Model/Catalog number
      • KD-401Q-0330
    2. UDI-DI
      • 04953170041648
      Model/Catalog number
      • KD-401Q-0720
    3. UDI-DI
      • 04953170042362
      • 04953170463778
      • 04953170466564
      Model/Catalog number
      • KD-431Q-0720
    4. UDI-DI
      • 04953170041709
      Model/Catalog number
      • KD-401Q-0730
    5. UDI-DI
      • 04953170466557
      Model/Catalog number
      • KD-411Q-0730
    6. Model/Catalog number
      • KD-411Q-0720
    7. UDI-DI
      • 04953170041587
      Model/Catalog number
      • KD-401Q-0320
    8. UDI-DI
      • 04953170041587
      Model/Catalog number
      • KD-401Q-0725

    Some entries omit identifying details. Check the notice to confirm which units are affected.

  3. Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

    Lot code
    All Lots with a valid expiration date
    1. Model/Catalog number
      • KD-VC411Q-0725
    2. UDI-DI
      • 04953170371233
      Model/Catalog number
      • KD-VC433Q-0730
    3. UDI-DI
      • 04953170371110
      Model/Catalog number
      • KD-VC411Q-0720
    4. UDI-DI
      • 04953170466434
      Model/Catalog number
      • KD-VC431Q-0730
    5. UDI-DI
      • 04953170466403
      Model/Catalog number
      • KD-VC411Q-0320
    6. UDI-DI
      • 04953170399329
      Model/Catalog number
      • KD-VC411Q-0730
    7. UDI-DI
      • 04953170371097
      Model/Catalog number
      • KD-VC411Q-0330
    8. UDI-DI
      • 04953170371158
      Model/Catalog number
      • KD-VC412Q-0215
    9. UDI-DI
      • 04953170371219
      Model/Catalog number
      • KD-VC433Q-0720

    Some entries omit identifying details. Check the notice to confirm which units are affected.

  4. CleverCut Single Use 3-Lumen Sphincterotome V

    UDI-DI
    • 04953170183973
    • 04953170466274
    • 04953170380556
    Model/Catalog number
    • KD-V411M-0320
    Lot code
    All Lots with a valid expiration date

  5. Single Use Sphincterotome V (Distal Wire guided)

    UDI-DI
    • 04953170466427
    Model/Catalog number
    • KD-VC431Q-0720
    Lot code
    All Lots with a valid expiration date

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, GU, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming and International: TBD.

Company
Olympus Corporation of the AmericasCenter Valley, Pennsylvania
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98252
Recall numbers
Z-1268-2026 to Z-1297-2026

All recalls from Olympus Corporation of the Americas

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)