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.
What this means for you
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 Product
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- fracture
- brittleness
- UV-damage
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.
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