FDA Device recall Z-1446-2026
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Olympus Resection Sheath, 28 Fr. with Deflecting Obturator 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-1446-2026 |
| 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, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Reason
Complaints of the ceramic tip of the resection sheath breaking have been received.
Identifiers
| code_info | Model No. A22043T; UDI: 04042761021012; 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-1446-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.