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-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief