Reported Aug 23, 2023 · Ongoing
UroPass Ureteral Access Sheaths, 5 pieces/box
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- UroPass Ureteral Access Sheaths, 5 pieces/box
- Lot codes and dates
- Models
61024BX61038BX61046BX61054BX61124BX61138BX61146BX61154BX61224BX61238BX61246BX61254BX61324BX61338BX61346BX61354BX
- LotsAll products manufactured in 2018 and 2019. Manufacturing date is printed on pouch label in YYYY-MM-DD format
- Models
- Amount recalled
- 9520 eaches
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Dilator tips may break in the package and in patients during surgical procedures.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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