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FDA · Medical devices ·

Halyard Product Name recall

AVID Medical, Inc. recalled Halyard Product Name on September 2, 2026 because of labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. It was sold nationwide.

Why it was recalled

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

What's recalled

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

Quantity: 45 kits

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
AVID Medical, Inc., Toano, VA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution in the states of MS, TX.
Status
Ongoing
Recall number
Z-3005-2026
Source
U.S. Food and Drug Administration

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