FDA DevicesClass II
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Published: July 8, 2026Recall ID: Z-2649-2026Category: devicesCountry: US
Reason for Recall / Hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Product Description & Identification
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Affected Products
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Additional Source Details
| Field | Value |
|---|---|
| City | Oberkochen |
| State | N/A |
| Event id | 99239 |
| Address 1 | Rudolf-Eber-Str. 11 |
| Address 2 | N/A |
| Code info | UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313 |
| Postal code | N/A |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 13 units |
| Reason for recall | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260601 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmCarl Zeiss Meditec AG
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.