FDA Medical devices recall ·
Olympus Inner Sheath, Long recall
- Recall number
- Z-1451-2026
- Date
- (initiated November 11, 2025)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,141 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Why was it recalled?
Complaints of the ceramic tip of the resection sheath breaking have been received.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. WA22017T; UDI: 04042761051521; All Lots.
Distribution
US Nationwide Distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1451-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.