FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath Model A2641 recalled for ceramic tip breakage risk
What this means
Olympus has recalled the Inner Sheath Model A2641, a medical device used in urological procedures. The ceramic tip of the resection sheath can break during use, which may affect the safety and effectiveness of the procedure.
- Stop using this device immediately if you have it in your facility
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Check your inventory for Model No. A2641 (UDI: 04042761004060)
The agency's original wording
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide Distribution.
Affected count
0 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1455-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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