Recall Z-3005-2026— AVID Medical, Inc.

Name: FDA recall Z-3005-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2026-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27. Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-09
Firm location: Toano, VA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.