FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Models A22014A and A22014T recalled for ceramic tip breakage
OTHERNationwide distribution
Stop using Olympus Resection Sheath immediately
The ceramic tip on Olympus Resection Sheath models A22014A and A22014T can break during use. These devices are used by doctors during urological procedures. The company has received complaints about this issue affecting 29 units nationwide.
- Stop using the affected Olympus Resection Sheath models immediately
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Alert your healthcare facility or doctor if you have one of these devices in use
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
29 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2026More 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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