Zeiss Intrabeam Spherical Applicator 1 — Class II medical device recall Z-2649-2026
Ongoing recall by Carl Zeiss Meditec AG, reported 2026-07-08, distributed nationwide. Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
| Recall number | Z-2649-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Oberkochen, N/A, Germany |
| Recall initiated | 2026-06-01 |
| Classified | 2026-07-01 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, DE, EC, ES, FR, MY, PH, PL, RO |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 04049539101563 |
| Lot numbers | A0002 |
| Serial numbers | A63086OUS, A63141 |
| Model numbers | 304534-6000-557 |
Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Reason for recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2649-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.