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Zeiss Intrabeam Spherical Applicator
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MEDICAL DEVICE RECALLMODERATE

Zeiss Intrabeam Spherical Applicator

Zeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.

What to do

Stop using the affected spherical applicator and contact Carl Zeiss Meditec AG for further instructions regarding the return or replacement of the device.

Posted
Updated
Recall No.
Z-2649-2026
Agency
Firm
Carl Zeiss Meditec AG
Recall ID
99239
Status
ONGOING

Why it was recalled

Carl Zeiss Meditec AG is recalling the 1.5 cm Spherical Applicator, a radiation therapy accessory, because the units failed to meet manufacturing specifications. The affected product is identified by REF 304534-6000-557.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UPC
04049539101563
Recall #
Z-2649-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification