Zeiss Intrabeam Spherical Applicator 1.5 cm recall
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Why was Zeiss Intrabeam Spherical Applicator 1.5 cm recalled?
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Recalling firm
- Carl Zeiss Meditec AG
- 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.
- Recall date
- July 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)