FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A2666T recalled for ceramic tip breakage
What this means
The ceramic tip on Olympus Resection Sheath Model A2666T can break during use. This device is used in urological procedures. The FDA has determined this poses a risk to patients.
- Stop using Model A2666T immediately if you have this device
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review your facility's inventory for Model A2666T (all lots affected)
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 Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2026More Olympus recalls
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