Notice names this product. Carl Zeiss Meditec AG’s Zeiss Intrabeam Spherical Applicator 1 is named in FDA Class II recall Z-2649-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. Identifying details: 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. Units affected: 13 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Company / brand: Carl Zeiss Meditec AG recalls
Affected product: Zeiss Intrabeam Spherical Applicator 1 recall status
Official ID Z-2649-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.