FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Inner Sheath Model A4741 recalled for ceramic tip breaking risk
OTHERNationwide distribution
Stop using Olympus Inner Sheath Model A4741
The ceramic tip on Olympus Inner Sheath Model A4741, used in gynecological endoscopy procedures, can break during use. The FDA has received complaints of this breakage. Approximately 91 units are affected nationwide.
- Stop using the Olympus Inner Sheath Model A4741 (UDI: 04042761006514)
- Contact Olympus Corporation of the Americas or your medical supplier for instructions on returning or replacing the device
- If you have already used this device in a procedure, notify your healthcare provider
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
91 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2026More Olympus Corporation of the Americas recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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