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Class IIOngoing

Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Carl Zeiss Meditec AG
Reason
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99239…

Products

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

    Codes/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, A6313Quantity: 13 unitsRecall no. Z-2649-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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