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

Date

July 8, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Carl Zeiss Meditec AG

Product

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

Reason

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

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.

Quantity

13 units

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

Recall started

June 1, 2026

Device type

System, Therapeutic, X-Ray

Root cause (FDA)

Employee error

What the company told customers

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.

Recall number

Z-2649-2026

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2649-2026. The agency record governs; check it and the company before acting.