Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
FDA Recall Z-2649-2026 · Posted 2026-07-01
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Recalling FirmCarl Zeiss Meditec AG
Recall StatusOpen, Classified
Product CodeJAD
Date Initiated2026-06-01
Product Quantity13 units
Reason for Recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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