FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22042T recalled for ceramic tip breaking
OTHERNationwide distribution
Stop using Olympus Resection Sheath A22042T
Olympus Corporation of the Americas is recalling the Resection Sheath 26 Fr. with Deflecting Obturator (Model A22042T), a medical device used in urologic procedures. The ceramic tip on this device can break during use, which may affect the procedure or patient safety.
- Stop using the Olympus Resection Sheath Model A22042T immediately.
- Contact your hospital or surgical facility if you have this device in stock.
- Check your equipment inventory for Model No. A22042T and UDI 04042761020992.
- Report any incidents or injuries to Olympus at 1-888-352-6387 or the FDA.
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
1,634 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- 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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