Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

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

On June 12, 2026, Carl Zeiss Meditech issued a Urgent Medical Device Recall to affected consignees via FedEx Priority. Carl Zeiss ask consignees to take the following actions: 1. Immediately discontinue use of any affected applicator identified in this notice and segregate/quarantine it to prevent further use. 2. Complete, sign, and return the attached Acknowledgement and Receipt Form to CZMUI in accordance with the instructions provided on the form. 3. Once the Acknowledgement and Receipt Form has been received by CZMUI, then a member of our service team will contact you to schedule the replacement of your applicator and collect the recalled applicator from you. 4. This recall letter should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.

• FDA enforcement recordOfficial FDA database entry for Z-2649-2026
• FDA 510(k) clearance · K121653The device's official FDA premarket clearance record
• FDA device classification · JADOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Carl Zeiss Meditec AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.