FDA Medical devices recall ·
Zeiss Intrabeam Spherical Applicator 1.5 cm recall
- Recall number
- Z-2649-2026
- Date
- (initiated June 1, 2026)
- Company / brand
- Carl Zeiss Meditec AG
Rudolf-Eber-Str. 11, Oberkochen, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Why was it recalled?
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Florida Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2649-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.