Recall Z-2649-2026— Carl Zeiss Meditec AG

Name: FDA recall Z-2649-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-01

Class II · Ongoing

Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2026-06-01. It names one FDA 510(k) clearance: K121653. Product: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557. Reason: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications..

Recalling firm: Carl Zeiss Meditec AG
Classification: Class II
Status: Ongoing
Initiated: 2026-06-01
Firm location: Oberkochen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSCarl Zeiss Meditec, Inc.·cleared 2012-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.