FDAHealthJune 1, 2026
Carl Zeiss Meditec AG — Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
⚠️ Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 1, 2026
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.
What's affected?
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Lot code
- 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
Additional details
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 should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13 units.
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