Z-2649-2026 Class II Ongoing
FDA device recall Z-2649-2026 was initiated by Carl Zeiss Meditec AG on June 1, 2026 and is designated Class II. Reason for recall: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- June 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Reason for Recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
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.
Code Information
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