Class II

Medical Device Recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Carl Zeiss Meditec AG · June 1, 2026

Reason for Recall

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

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.

States Affected

NATIONWIDE

Quantity Affected

13 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2649-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Carl Zeiss Meditec AG Medical Device Recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | SafeCheck