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Olympus Single Use 3-Lumen Sphincterotome V
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MEDICAL DEVICE RECALLMODERATE

Olympus Single Use 3-Lumen Sphincterotome V

Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a risk of deformation and performance loss.

What to do

Immediately stop using the affected sphincterotome and contact Olympus for return instructions.

Recalled
Listed
Updated
Recall No.
Z-1271-2026
Agency
FDA
Firm
Olympus Corporation of the Americas
Recall ID
98252
Status
ONGOING

Why it was recalled

Olympus is recalling the Single Use 3-Lumen Sphincterotome V due to a manufacturing defect where units that did not undergo thermoforming may deform and lose performance during use. This recall was distributed nationwide.

Is mine affected?

This recall covers 30 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DIModel/Catalog number
Single Use 3-Lumen Sphincterotome VZ-1271-202604953170380563, 04953170380563, 04953170380563KD-V411M-0330
Disposable Triple Lumen SphincterotomeZ-1287-202604953170041617KD-401Q-0330
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1297-2026–KD-VC411Q-0725
CleverCut Single Use 3-Lumen Sphincterotome VZ-1268-202604953170183973, 04953170466274, 04953170380556KD-V411M-0320
Single Use Sphincterotome V (Distal Wire guided)Z-1269-202604953170466427, 04953170466427, 04953170466427KD-VC431Q-0720
Single Use 3-Lumen Sphincterotome VZ-1290-202604953170380600KD-V411M-1520
Disposable Triple Lumen SphincterotomeZ-1288-202604953170041648KD-401Q-0720
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1284-202604953170371233, 04953170371233, 04953170371233KD-VC433Q-0730
Show all 30 products
ProductRecall #UDI-DIModel/Catalog number
Single Use 3-Lumen Sphincterotome VZ-1273-202604953170380587, 04953170380587KD-V411M-0725
Disposable Triple Lumen SphincterotomeZ-1270-202604953170042362, 04953170463778, 04953170466564KD-431Q-0720
Disposable Triple Lumen SphincterotomeZ-1289-202604953170041709KD-401Q-0730
Single Use 3-Lumen Sphincterotome VZ-1296-2026–KD-V411M-3025
Disposable Triple Lumen SphincterotomeZ-1286-202604953170466557, 04953170466557, 04953170466557KD-411Q-0730
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1278-202604953170371110, 04953170371110, 04953170371110KD-VC411Q-0720
Single Use 3-Lumen Sphincterotome VZ-1275-202604953170184178, 04953170184178, 04953170184178KD-V431M-0720
Disposable Triple Lumen SphincterotomeZ-1285-2026–KD-411Q-0720
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1277-202604953170466434, 04953170466434, 04953170466434KD-VC431Q-0730
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1280-202604953170466403, 04953170466403, 04953170466403KD-VC411Q-0320
Single Use 3-Lumen Sphincterotome VZ-1274-202604953170380594, 04953170380594KD-V411M-0730
Single Use 3-Lumen Sphincterotome VZ-1276-202604953170380648, 04953170380648, 04953170380648KD-V431M-0730
Single Use 3-Lumen Sphincterotome VZ-1292-202604953170184154KD-V411M-3030
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1279-202604953170399329, 04953170399329, 04953170399329KD-VC411Q-0730
Single Use 3-Lumen Sphincterotome VZ-1295-2026–KD-V411M-3020
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1281-202604953170371097, 04953170371097, 04953170371097KD-VC411Q-0330
Single Use 3-Lumen Sphincterotome VZ-1291-202604953170380617KD-V411M-1530
Disposable Triple Lumen SphincterotomeZ-1293-202604953170041587KD-401Q-0320
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1282-202604953170371158, 04953170371158, 04953170371158KD-VC412Q-0215
Disposable Triple Lumen SphincterotomeZ-1294-202604953170041587KD-401Q-0725
Single Use 3-Lumen Sphincterotome VZ-1272-202604953170184017, 04953170380570KD-V411M-0720
Single Use 3-Lumen Sphincterotome V (Distal Wire guided)Z-1283-202604953170371219, 04953170371219, 04953170371219KD-VC433Q-0720

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification