FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 24 Fr recalled for ceramic tip breaking
OTHERNationwide distribution
Stop using Olympus Resection Sheath 24 Fr
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
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
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- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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