Class II
Medical Device Recall: Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
AVID Medical, Inc. · July 9, 2026
Reason for Recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Distribution
US Nationwide distribution in the states of MS, TX.
States Affected
NATIONWIDE
Quantity Affected
45 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3005-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.