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MEDICAL DEVICE RECALLMODERATE
Olympus Single Use 3-Lumen Sphincterotome V
Olympus is recalling the Single Use 3-Lumen Sphincterotome V due to a manufacturing defect that may cause the device to deform.
What to do
Stop using the affected devices immediately and contact Olympus for further instructions regarding the return or replacement of the product.
Why it was recalled
Devices which did not undergo thermoforming could deform and lose performance.
How to identify it
UPC 04953170380563 04953170380563 04953170380563
Product Name: Single Use 3-Lumen Sphincterotome V
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Olympus Corporation of the Americas
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification