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FDA
Food and Drug Administration · Recall Z-2649-2026 · Jun 1, 2026

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Carl Zeiss Meditec AG

The hazard

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model A63086 OUS (Outside the US) - A63085Model A63096Model A63101Model A63102Model A63105Model A63107Model A63108Model A63109Model A63110Model A63112Model A6313UPC 04049539101563

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.