Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026

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

Carl Zeiss Meditec AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carl Zeiss Meditec AG · Rudolf-Eber-Str. 11 · Oberkochen

Is this the product you have?

  • Zeiss Intrabeam Spherical Applicator 1.5
  • cm REF304534-6000-557
Lot codes and dates
  • UDI(01)04049539101563
  • Batch noA0002
  • Serial numbers
    • US - A63141
    • A63086 OUS (Outside the US) - A63085
    • A63096
    • A63101
    • A63102
    • A63105
    • A63107
    • A63108
    • A63109
    • A63110
    • A63112
    • A6313
Amount recalled
13 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 6:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.