FDAFDA recall Z-2649-2026 · Jul 8, 2026
Carl Zeiss Meditec AG: Zeiss Intrabeam Spherical Applicator 1 recall
Recall found
Product
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Reason for recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- 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.
- Recalling firm
- Carl Zeiss Meditec AG, Oberkochen, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-01
Source: openFDA enforcement record Z-2649-2026 · search recall number Z-2649-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.