RecalledThisWeek Search
Medium risk Medical DevicesClass II

Olympus Sphincterotome V Recall

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These inst

Updated January 7, 2026

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V instruments because some units may not have been properly heat-formed, causing them to deform and lose performance during use. These surgical devices are used during endoscopy procedures to open the bile duct.

Is the Olympus Corporation of the Americas recalled? Yes. This product was recalled by FDA on January 7, 2026. Details below.

What is recalled

Olympus Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0330. These single-use surgical instruments are designed for use with an Olympus endoscope and guidewire during papillotomy procedures.

Am I affected

You are affected if you have this device in your facility or if you underwent a procedure using model KD-V411M-0330 on or before the recall date. Check the model number on the packaging or device label.

What to do right now

Contact Olympus Corporation of the Americas immediately to report any affected units and arrange return or replacement. If you underwent a procedure with this device and have concerns about the outcome, speak with your healthcare provider.

The hazard

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

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1271-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

Get free recall alerts

New Medical Devices recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Medical Devices recalls