FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Model A2666 resection sheath recalled for ceramic tip breakage
What this means
Olympus has recalled its Model A2666 resection sheath, a medical device used in urologic procedures, because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting all lots of this device.
- Stop using this device immediately if you have it in stock or in use
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Verify the model number (A2666) and UDI (04042761004244) on your device
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
1 unit
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2026More Olympus recalls
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