FDA DevicesClass II
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatmen...
Published: March 4, 2026Recall ID: Z-1454-2026Category: devicesCountry: US
Reason for Recall / Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Product Description & Identification
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Affected Products
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98288 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model No. A37004A; UDI: 04042761023092; All Lots. |
| Postal code | 18034-8229 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 94 units |
| Reason for recall | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251111 |
| Initial firm notification | Letter |
| Center classification date | 20260220 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide Distribution.