Z-2269-2024Class II

Pink Luminous Breast, Breast transilluminator

Name: Z-2269-2024 Pink Luminous Breast, Breast transilluminator
Creator: Silkprousa LLC
Published: 2024-05-20
License: https://open.fda.gov/license/

Silkprousa LLC / initiated 2024-05-20 / Open, Classified

FDA source

Silkprousa LLC began a recall of Pink Luminous Breast, Breast transilluminator on 2024-05-20. FDA classified it as Class II and gives the reason as "Firm is marketing and distributing the Pink Luminous Breast device without premarket approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2269-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-20
Posted: 2024-07-05
Recalling firm: Silkprousa LLC
Product: Pink Luminous Breast, Breast transilluminator
Product code: LEK Transilluminator (Diaphanoscope)
Reason for recall: Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
FDA 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 in commerce: 2000 devices
Distribution: US Nationwide distribution in the states of WA, RI.
Product codes and lots: Product is not lot coded, all devices are subject

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2269-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2269-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05

Product code LEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)