FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22043T recalled for ceramic tip breakage
What this means
The ceramic tip on Olympus Resection Sheath Model A22043T (28 Fr. with Deflecting Obturator) can break during use. This device is used in urologic surgical procedures. The FDA has identified 207 affected units across the US.
- Stop using this device immediately if you have it in your facility
- Check your inventory for Model No. A22043T with UDI 04042761021012
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review any procedures performed with this device and consult with your medical team if needed
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
207 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1446-2026More Olympus recalls
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- 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
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