Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 recall (Carl Zeiss Meditec AG)
Medical deviceClass IIOngoing
Summary: Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557. Reason: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What is being recalled
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Why
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - 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. (states named: Florida, Puerto Rico)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2649-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 1, 2026 |
| Reported | July 8, 2026 |
| Company | Carl Zeiss Meditec AG |
| Company location | Oberkochen, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 13 units |
More recalls from Carl Zeiss Meditec AG · all medical device recalls · recalls from June 2026