Zeiss Intrabeam Spherical Applicator 1.5 cm recallZ-2649-2026 · Carl Zeiss Meditec AG · initiated Jun 1, 2026
Class II Open, Classified All recalls posted in July 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carl Zeiss Meditec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
FDA root cause category: Employee error
What the company is doing
On June 12, 2026, Carl Zeiss Meditech issued a Urgent Medical Device Recall to affected consignees via FedEx Priority. Carl Zeiss ask consignees to take the following actions: 1. Immediately discontinue use of any affected applicator identified in this notice and segregate/quarantine it to prevent further use. 2. Complete, sign, and return the attached Acknowledgement and Receipt Form to CZMUI in accordance with the instructions provided on the form. 3. Once the Acknowledgement and Receipt Form has been received by CZMUI, then a member of our service team will contact you to schedule the replacement of your applicator and collect the recalled applicator from you. 4. This recall letter should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
Recall details
- Recall number
- Z-2649-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Carl Zeiss Meditec AG
- Quantity
- 13 units
- Product code
- JAD
- FDA submissions
- K121653
- 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.
Product description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTRABEAM® Spherical Applicator 1.5 cm 304534-6000-557Carl Zeiss Meditec AG · System, Therapeutic, X-Ray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page