# FDA recall Z-2269-2024

> **Silkprousa LLC** · Class II · device recall initiated 2024-05-20.

## Product

Pink Luminous Breast, Breast transilluminator

## Reason for recall

Firm is marketing and distributing the Pink Luminous Breast device without premarket approval

## Distribution

US Nationwide distribution in the states of WA, RI.

## Key facts

- **Recall number:** Z-2269-2024
- **Recalling firm:** Silkprousa LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-20
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2024

## Citation

> AI Analytics. FDA recall Z-2269-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2269-2024. Source: US FDA. Licensed CC0.

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