FDA DevicesClass II
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urolo...
Published: March 4, 2026Recall ID: Z-1445-2026Category: devicesCountry: US
Reason for Recall / Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Product Description & Identification
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Affected Products
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. 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. A22043A; UDI: 04042761021005; All Lots. |
| Postal code | 18034-8229 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 118 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.