Olympus Resection Sheath — Class II medical device recall Z-1446-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-03-04, distributed nationwide. Complaints of the ceramic tip of the resection sheath breaking have been received.
| Recall number | Z-1446-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-11-11 |
| Classified | 2026-02-20 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 207 units |
| UPC / GTIN / UDI-DI | 04042761021012 |
| Model numbers | A22043T |
Product
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Reason for recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1446-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.