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U.S. Department of Health and Human Services

Class 2 Device Recall Zeiss Intrabeam Spherical Applicator 1.5 cm

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 Class 2 Device Recall Zeiss Intrabeam Spherical Applicator 1.5 cmsee related information
Date Initiated by FirmJune 01, 2026
Date PostedJuly 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2649-2026
Recall Event ID 99239
510(K)NumberK121653 
Product Classification System, therapeutic, x-ray - Product Code JAD
ProductZeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Code Information UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313
FEI Number 3003481798
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Rudolf-Eber-Str. 11
Oberkochen Germany
For Additional Information ContactLucia Puettmann
497364-20-2555
Manufacturer Reason
for Recall		Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
FDA Determined
Cause 2		Employee error
ActionOn 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.
Quantity in Commerce13 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAD
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