Quick Facts at a Glance
- Recall Date
- June 1, 2026
- Hazard Level
- HIGH
- Brand
- Carl Zeiss Meditec AG
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Carl Zeiss Meditec AG
- Model numbers
- UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108 +4 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 1, 2026
Reported by FDA DEVICE
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Carl Zeiss Meditec AG or your healthcare provider for instructions. Notification method: Letter
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Full Description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557. Reason: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.. Classification: Class II. Quantity: 13 units. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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