FDA recall Z-2649-2026

Carl Zeiss Meditec AG · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2026-06-01
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oberkochen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2026