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Medium risk Drugs & MedicationsClass II

Olympus Corporation of the Americas Recall

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product De

Updated January 7, 2026

Olympus Corporation of the Americas is recalling Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product De. Hazard: Devices which did not undergo thermoforming could deform and lose performance.

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

What is recalled

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1284-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

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