Z-2649-2026Class II

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Name: Z-2649-2026 Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Creator: Carl Zeiss Meditec AG
Published: 2026-06-01
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2026-06-01 / Open, Classified / root cause: manufacturing process

FDA source

Carl Zeiss Meditec AG began a recall of Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 on 2026-06-01. FDA classified it as Class II and gives the reason as "Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2649-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-01
Posted: 2026-07-01
Recalling firm: Carl Zeiss Meditec Inc
Product: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 13 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2649-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2649-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code JAD

K121653Class IIIntrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. / cleared 2012-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)