UroPass Ureteral Access Sheaths Recalled for Dilator Tip Breakage
Olympus is recalling UroPass Ureteral Access Sheaths because dilator tips may break during surgical procedures or while in the package. The recall affects 9,520 units manufactured in 2018 and 2019.
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 medical device recall where dilator tips may break during surgical procedures. No patient injuries, hospitalizations, or deaths have been reported in the source material. It meets the High severity criterion as a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Olympus Corporation of the Americas is recalling UroPass Ureteral Access Sheaths, medical devices used in urological surgical procedures. The recalled devices are supplied in 5-piece boxes under model numbers 61024BX through 61354BX.
The recall has been issued because dilator tips may break while the product is in the package or during surgical procedures.
The recall affects 9,520 units manufactured in 2018 and 2019. Manufacturing dates are printed on pouch labels in YYYY-MM-DD format. The devices have been distributed worldwide, including to the United States, South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
The recalled product
- Product
- UroPass Ureteral Access Sheaths, 5 pieces/box
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 9,520
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 (15)
- Models: 61024BX
- 61038BX
- 61046BX
- 61054BX
- 61124BX
- 61138BX
- 61146BX
- 61154BX
- 61224BX
- 61238BX
- 61246BX
- 61254BX
- 61324BX
- 61338BX
- 61346BX
Distribution
Distributed nationwide across the United States.
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