CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Zeiss Intrabeam Spherical Applicator recalled by Carl Zeiss Meditec AG

Carl Zeiss Meditec is recalling Zeiss Intrabeam Spherical Applicator, distributed nationwide in the US. The recall was initiated on 1 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (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

Quantity recalled13 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2649-2026
FDA event ID: 99239
Recalling firm: Carl Zeiss Meditec, Oberkochen, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 1 Jun 2026
FDA classified: 1 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Jun 2026	Recall initiated by company
1 Jul 2026	Classified by FDA	+30 days
8 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Florida Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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