FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 24 Fr recalled for ceramic tip breaking
What this means
Olympus has recalled the Resection Sheath, 24 Fr (Model A22041A), a urologic medical device, because the ceramic tip can break during use. The company has received multiple complaints about this problem. About 3,484 units are affected nationwide.
- Stop using the device immediately if you have one in your facility
- Contact Olympus for instructions on returning or replacing affected units
- Check your inventory for Model A22041A with any lot number
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
3,484 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1441-2026More 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
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