FDA Closes AVID Medical Recall of 45 DaVinci Custom Bundle Kits
The FDA has terminated the Class II recall of 45 Halyard DaVinci TruCustom bundles over a labeling deficiency, meaning the agency considers the action carried out.
2 reports on this incident · first at Sep 9, 2026, 9:18 p.m. ET
Earlier reports
Sep 9, 2026, 9:18 p.m. ETFirst report
AVID Medical Recalls 45 DaVinci Custom Bundle Kits Over Latex Labeling Deficiency
AVID Medical, Inc. of Toano, Virginia, is recalling 45 DaVinci TruCustom bundles containing a 16 French Foley catheter tray with a StatLock device because the kit labeling fails to identify that the StatLock component contains natural rubber latex, according to an FDA enforcement report dated September 2, 2026.
The recall, number Z-3005-2026, was initiated on July 9, 2026, and is ongoing, the report states. The affected product is identified by brand name Halyard, product name DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK, model/catalog number SAMM064-27, and lot number 1634391 with UDI 10809160439708. The kits were distributed in Mississippi and Texas, according to the report.
The FDA classifies this as a Class II recall, its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA's enforcement database records no other enforcement action by this firm.
The recall remains ongoing.
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- Version 110 Sept 2026, 01:18current
First published.
- Version 110 Sept 2026, 01:23current
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