Z-1271-2026Class II

Olympus Corporation of the Americas

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-02-11

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

Firm state

Product quantity

33433 units (36 US, 33397 OUS)

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; 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.

Code / lot info

Model/Catalog Number: KD-V411M-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; All Lots with a valid expiration date

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →