Zeiss Intrabeam Spherical Applicator Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Carl Zeiss Meditec AG is recalling 13 units of the Zeiss Intrabeam Spherical Applicator 1.5 cm due to failure to meet manufacturing specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Carl Zeiss Meditec AG initiated a voluntary recall of spherical applicators used as a radiation therapy accessory because the products failed to meet manufacturing specifications.
Which Products Are Affected
The recall affects the Zeiss Intrabeam Spherical Applicator 1.5 cm (REF: 304534-6000-557). A total of 13 units are involved, identified by UDI (01)04049539101563, Batch no: A0002, and the following serial numbers: US - A63141, A63086; OUS - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313. Distribution includes US nationwide in Florida and Puerto Rico, as well as China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
What You Should Do
Consumers and healthcare facilities should contact the recalling firm for additional information regarding the recall.
Why This Matters
This Class II recall involves a radiation therapy accessory distributed worldwide, including multiple US territories.
Source
FDA recall number Z-2649-2026, report date 20260708.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,060 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.