Notice names this product. AVID Medical’s Brand Name is named in FDA Class II recall Z-3005-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Identifying details: Lot Code: Lot Number: 1634391 UDI: 10809160439708. Units affected: 45 kits. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Brand Name recall status
Official ID Z-3005-2026 · Official record ↗
See all AVID Medical recalls →
Found something wrong or missing? Report a data error.
Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.