← FDA ENFORCEMENT
Z-1441-2026Class II
Olympus Corporation of the Americas
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-03-04
Distribution
US Nationwide Distribution.
Firm state
PA
Product quantity
3,484 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Product description
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Code / lot info
Model No. Model No. A22041A; UDI: 04042761020961; All Lots.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →