FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath Model A2642 recalled for ceramic tip breakage risk
What this means
The ceramic tip on Olympus Inner Sheath Model A2642, used in urological endoscopic procedures, can break during use. The FDA has received complaints of this breakage occurring.
- Stop using Olympus Inner Sheath Model A2642 immediately
- Contact Olympus Corporation of the Americas for instructions on replacement or return
- If you have already used this device, contact your healthcare provider
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. A2642. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1456-2026More Olympus recalls
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