FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath 21 Fr. Model A2660T recalled for ceramic tip fracture risk
What this means
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
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 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 recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.