# FDA recall Z-2649-2026

> **Carl Zeiss Meditec AG** · Class II · device recall initiated 2026-06-01.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-2649-2026
- **Recalling firm:** Carl Zeiss Meditec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-01
- **Report date:** 2026-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oberkochen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2026

## Citation

> MORVS. FDA recall Z-2649-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2649-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*