FDA Device recall Z-1448-2026
Olympus Resection Sheath, 8 mm
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Olympus Resection Sheath, 8 mm 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-1448-2026 |
| 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, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Reason
Complaints of the ceramic tip of the resection sheath breaking have been received.
Identifiers
| code_info | Model No. A42011A; UDI: 04042761023658; 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-1448-2026%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.