FDA-Device2026-07-08Class IIPROCESSING DEFECT
Zeiss Intrabeam Spherical Applicator 1.5 cm recalled for manufacturing specification failure
What this means
Certain Zeiss Intrabeam Spherical Applicator 1.5 cm units used in intraoperative radiation therapy did not meet manufacturing specifications. A total of 13 units were affected across the United States, Puerto Rico, and several other countries. No injuries have been reported.
- If your facility uses a Zeiss Intrabeam Spherical Applicator 1.5 cm, verify the serial number against the list provided in this recall notice.
- Contact Zeiss Meditec or your distributor for return instructions or a replacement unit.
- Do not use the affected applicator until you have confirmed it is not part of the recall.
The agency's original wording
Hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
Affected count
13 units
Manufactured in
Rudolf-Eber-Str. 11, N/A, Oberkochen, N/A, Germany
Products
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2026Want us to check the next one for you?
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