FDA recall, , Moderate risk
Zeiss Intrabeam Spherical Applicator 1.5 cm
The Zeiss Intrabeam Spherical Applicator 1.5 cm failed to meet manufacturing specifications.
Summary by Recall Canary from the FDA notice
What happened
Carl Zeiss Meditec AG, based in Oberkochen, Germany, recalled the Zeiss Intrabeam Spherical Applicator 1.5 cm, a radiation therapy accessory, because the applicators failed to meet manufacturing specifications. The company began the recall on June 1, 2026, and the U.S. Food and Drug Administration added it to its Enforcement Report on July 1, 2026, with the weekly report published on July 8, 2026.
The recalled product is identified as the Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557. The recall affected 13 units distributed in the United States in Florida and Puerto Rico, as well as in China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- UDI-DI
- 04049539101563
- Lot code
- A0002
Recall details
- Company began the recall
- Sold in
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.
- Company
- Carl Zeiss Meditec AGOberkochen, Germany
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99239
- Recall number
- Z-2649-2026
- Quantity recalled
- 13 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
