AVID Medical, Inc. recalls Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/
- Recalling company
- AVID Medical, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 9, 2026
- Reported
- Sep 2, 2026
- Distribution
- US Nationwide distribution in the states of MS, TX.
- Status
- Ongoing
- Quantity
- 45 kits
- Lot / codes
- Lot Code: Lot Number: 1634391 UDI: 10809160439708
- Company location
- Toano, VA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3005-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3005-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.