FDAFDA · Food and drugs·Recall number Z-2649-2026
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Published July 8, 2026 · Recall initiated: June 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec AG
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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