FDA-Device2023-08-23Class II
UroPass Ureteral Access Sheaths, 5 pieces/box
Hazard
Dilator tips may break in the package and in patients during surgical procedures.
Sold states
Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Affected count
9520 eaches
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
UroPass Ureteral Access Sheaths, 5 pieces/box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2023More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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