Zeiss Intrabeam Spherical Applicator 1.5 cm Recall: Manufacturing Defect
Carl Zeiss Meditec recalls specific Zeiss Intrabeam Spherical Applicators due to failing to meet manufacturing specifications. Affected units include certain serial numbers and batch numbers. Consumers should contact the manufacturer for details.
Recall notice
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Contact the company
What happened, in plain English
Carl Zeiss Meditec is recalling specific models of their 1.5 cm Spherical Applicators used in radiation therapy. The recall is because these devices did not meet required manufacturing standards, which could lead to improper function during medical procedures. Read more at govinfonow.com/recall/49047-zeiss-intrabeam-spherical-applicator-1-5-cm-recall-manufacturing-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/49047-zeiss-intrabeam-spherical-applicator-1-5-cm-recall-manufacturing-defect · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2649-2026
Cite this page
“Zeiss Intrabeam Spherical Applicator 1.5 cm Recall: Manufacturing Defect.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49047-zeiss-intrabeam-spherical-applicator-1-5-cm-recall-manufacturing-defect. Based on FDA recall #Z-2649-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2649-2026%22&limit=1).
Why it’s dangerous
The spherical applicators failed to meet manufacturing specifications, meaning they might not function correctly during radiation therapy procedures. This could result in improper treatment delivery or other complications.
Who’s affected
Medical professionals using radiation therapy equipment are most likely affected. Patients receiving treatment with these applicators may also be impacted if the device fails.
How to tell if you have this one
Check for the serial numbers: US - A63141, A63086 or OUS - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313. Also look for batch number A0002 and reference number REF:304534-6000-557.
- Brand
Carl Zeiss Meditec- Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Carl Zeiss Meditec for specific instructions on how to return or replace the affected device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2649-2026 (June 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2649-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.