FDA Medical Device Recalls (openFDA)
Silkprousa LLC: Pink Luminous Breast, Breast transilluminator
- Recall number
- Z-2269-2024
- Recalling firm
- Silkprousa LLC
- Product
- Pink Luminous Breast, Breast transilluminator
- Status
- Open, Classified
- Initiated
- 2024-05-20
- Posted
- 2024-07-05
- Terminated
- not on file
- Reason
- Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
- Root cause
- No Marketing Application
- Action
- SilkProUSA issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/16/2024 via FedEx air. The notice explained the issue, the potential risk to health, and requested the consignee quarantine all inventory and notify those to whom they distributed the product. The firm is seeking the return of the affected product.
- Quantity
- 2000 devices
- Distribution
- US Nationwide distribution in the states of WA, RI.
- Lot, serial or model codes
- Product is not lot coded, all devices are subject
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LEK
- Firm FEI
- 3013213867
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28