FDA DevicesClass II
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Res...
Published: March 4, 2026Recall ID: Z-1439-2026Category: devicesCountry: US
Reason for Recall / Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Product Description & Identification
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Affected Products
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic 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. A22040A; UDI: 04042761029339; All Lots. |
| Postal code | 18034-8229 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 6,949 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.