Agency classClass IIOur severity:High FDA (Devices)·Z-0364-2025·Announced 2024-11-20

Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a surgical device where ultraviolet exposure can cause device fracture (dilator tip brittleness) without any reported injuries or deaths. The device could fracture during a surgical procedure, classifying it as a risk-of-harm product where injury has not yet been reported, meeting the High (3) severity threshold.

Plain-English summary

Olympus Corporation of the Americas is recalling UroPass Ureteral Access Sheath Sets worldwide. These medical devices consist of a hydrophilic-coated outer sheath and inner tapered dilator designed to create a passage for endoscopes and retrieval devices during urological procedures. The sheath sets are intended for single use only. Approximately 14,093 units have been distributed, including throughout the United States and internationally to Australia, Canada, China, Germany, Hong Kong, Japan, South Korea, and Singapore.

The recall was initiated because ultraviolet (UV) radiation exposure can cause the dilator tip to become brittle and break. Device breakage may occur while the sheath set is still in its package or during a surgical procedure.

The recalled product

Product: Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical instruments
Hazard: fracture
brittleness
UV-damage
Affected units: 14,093

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

Model/UDI-DI: 61024BX/00821925035317
61038BX/00821925035324
61046BX/00821925035331
61054BX/00821925035348
61124BX/00821925035355
61138BX/00821925035362
61146BX/00821925035379
61154BX/00821925035386
61224BX/00821925035393
61238BX/00821925035409
61246BX/00821925035416
61254BX/00821925035423
61324BX/00821925035430
61338BX/00821925035447
61346BX/00821925035454
61354BX/00821925035461.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Olympus Corporation of the Americas

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