Summary
The FDA issued a Class II for Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 by Carl Zeiss Meditec AG. Reason: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications..
Details
Source
Device Recall
External ID
Z-2649-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Lot/Code Info: 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
Quantity Affected: 13 units
Reason for Recall
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-01
Company
Oberkochen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Carl Zeiss Meditec AG has 14 FDA actions in our database, including 2 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carl Zeiss Meditec AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carl Zeiss Meditec AG have FDA actions?
Carl Zeiss Meditec AG has 14 FDA actions in our database, including 2 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2649-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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