Silkprousa recalls Pink Luminous Breast transilluminators sold without FDA premarket approval. Consumers should check if they own this device and contact the company for details.
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Silkprousa is recalling all Pink Luminous Breast transilluminators because they were sold without FDA premarket approval. This means the device may not be safe for medical use.
The device was sold without FDA premarket approval, meaning it hasn't been tested for safety and effectiveness. This could lead to improper medical procedures or harm if used without proper oversight.
Anyone who owns or uses the Pink Luminous Breast device. Medical professionals using the device for breast imaging are most at risk.
The Pink Luminous Breast transilluminator is sold without lot numbers. All devices are subject to recall.
Look for the product name 'Pink Luminous Breast' or 'Breast transilluminator' without lot numbers.
The device was sold without FDA premarket approval, meaning it hasn't been tested for safety and effectiveness.
The device is sold without lot numbers and is labeled as 'Pink Luminous Breast' or 'Breast transilluminator'.
The recall record does not specify a remedy, so contact Silkprousa directly for guidance.
We’ve drafted a message you can send Silkprousa to request your refund or repair — edit it as you like.
Subject: Recall Z-2269-2024 — Silkprousa Silkprousa Hello, I own a Silkprousa that is covered by recall Z-2269-2024 from Silkprousa. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
