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FDA flags 8 unregistered medical devices

Published Apr 25, 2024 01:30 am

The Food and Drug Administration (FDA) issued a warning to the public regarding the purchase and use of medical devices that have not undergone its evaluation process.

FDA-Advisory-No.2024-0659.png
Photo from FDA website

In an advisory on Wednesday, April 24, FDA identified eight medical devices that are not considered safe.

Unregistered device products include “Vantage Powder-Free Nitrile Examination Gloves,” “Kofuku Health Massager Tens Therapy,” “Yoshi Adult Diapers,” “Sureshot Disposable Syringe with expired Certificate Of Product Registration,” “Surgitech Hypo-Allergenic Surgical Gloves Powder Free Natural Rubber Latex,” “Medical Depot Urine Bag,” “Commode Wheelchair Black,” and “Commode with Foam.”

The FDA's Post-Marketing Surveillanceoperations confirmed that these devices products did not go through the agency's registration process and lacked the required authorization in the form of a Certificate of Product Registration.

It warned all concerned establishments not to distribute, advertise, or sell these “violative medical device products” until they obtain the required Product Notification Certificate.

Failure to comply may result in regulatory actions and sanctions, the FDA said.

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