FDA Device recall Z-2649-2026
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 by Carl Zeiss Meditec Ag, citing spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2649-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-01 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Carl Zeiss Meditec Ag |
| Distribution | US |
Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Reason
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Identifiers
| code_info | UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2649-2026%22
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