TemporaryFDAOngoing
Can cause harm that is usually temporary.
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Check the device or its packaging for
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
- Why
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Distributed
- 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.
- Company
- Carl Zeiss Meditec AG
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2649-2026 · retrieved 1 July 2026
Read the official notice