medical MODERATE Updated 2026-07-08

Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for Zeiss Intrabeam Spherical Applicator →

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