Class II — Carl Zeiss Meditec AG
| Recalling firm | Carl Zeiss Meditec AG (Jena) |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| Product | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 |
| Quantity | 13 units |
| 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. |
| Initiated | 2026-06-01 |
| Classified | 2026-07-01 |
| Recall number | Z-2649-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carl Zeiss Meditec AG (Z-2649-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99239/
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