FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath 21 Fr. Model A2660T recalled for ceramic tip fracture risk
OTHERNationwide distribution
Contact Olympus about recalled urological sheath
Olympus has recalled the Inner Sheath 21 Fr. Model No. A2660T, a medical device used in urological procedures. The ceramic tip on the resection sheath can break during use, which could affect the safety and effectiveness of the procedure.
- If you have this device (Model No. A2660T, UDI: 04042761004183), contact Olympus Corporation of the Americas immediately
- Do not use the device until you speak with Olympus or your healthcare provider
- Ask your healthcare facility to check inventory for affected units
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
1 unit
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1453-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
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- 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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