Recalling firm
Carl Zeiss Meditec AG
Product type
Device
Status
Ongoing
Report date
2026-07-08
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.
Firm state
N/A
Product quantity
13 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Product description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Code / lot info
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
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.