fda_recall · device_recall · high

Carl Zeiss Meditec AG — Class II recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Event date
2026-07-08 00:00:00Z
Observed
2026-07-14 04:20:20Z
Source ID
Z-2649-2026
Payload hash
0aff1fc595bb02645478a9c7

Summary

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. Status: Ongoing.

Frequently asked questions

Has Carl Zeiss Meditec AG had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for Carl Zeiss Meditec AG as of 2026-07-14. Argus ingests new FDA enforcement records daily.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Carl Zeiss Meditec AG — Class II recall: Zeiss Intrabeam Spherical Applicator 1.5 cm  REF:304534-6000-557. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-carl-zeiss-meditec-ag-z-2649-2026
MLA
"Carl Zeiss Meditec AG — Class II recall: Zeiss Intrabeam Spherical Applicator 1.5 cm  REF:304534-6000-557." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-carl-zeiss-meditec-ag-z-2649-2026.
Chicago
Argus HQ Research. "Carl Zeiss Meditec AG — Class II recall: Zeiss Intrabeam Spherical Applicator 1.5 cm  REF:304534-6000-557." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-carl-zeiss-meditec-ag-z-2649-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_carl_zeiss_meditec_ag_z_2649_2026_2026,
  title = {Carl Zeiss Meditec AG — Class II recall: Zeiss Intrabeam Spherical Applicator 1.5 cm  REF:304534-6000-557},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-carl-zeiss-meditec-ag-z-2649-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.