Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Recalling company
- Carl Zeiss Meditec AG
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Reason
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 1, 2026
- Reported
- Jul 8, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 13 units
- Lot / codes
- 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
- Company location
- Oberkochen, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2649-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2649-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.