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FDAClass II · Medical device · Recalled July 8, 2026
Zeiss Intrabeam Spherical Applicator 1 recall — Carl Zeiss Meditec AG
Hazard: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2649-2026
- Brand
- Carl Zeiss Meditec AG
- Classification
- Class II
- Units affected
- 13 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Affected products
Companies & origin
- Recalling firm location
- Oberkochen, N/A, Germany
- Firm address
- Rudolf-Eber-Str. 11, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- 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
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99239
- Recall initiated
- June 1, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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