- Recalling firm
- Carl Zeiss Meditec AG
- Reason for recall
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Affected products (lot / model / serial)
- 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
- Units affected
- 13 units
- Distribution pattern
- 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.
- Firm location
- Oberkochen, N/A, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2649-2026
- Recall initiated
- June 1, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99239
- Last updated on HTM Vibe
- July 23, 2026