FDA Device recall Z-1438-2026
Olympus Resection Sheath
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Olympus Resection Sheath by Olympus, citing complaints of the ceramic tip of the resection sheath breaking have been received.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1438-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-11 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Reason
Complaints of the ceramic tip of the resection sheath breaking have been received.
Identifiers
| code_info | Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1438-2026%22
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