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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.

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

Recall at a glance

Quantity recalled
13 units

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

Lot code
A0002
UDI-DI
04049539101563

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Failed Specifications recalls

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