FDA Device recall Z-3005-2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27 by Avid Medical, citing labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3005-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-09 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: Lot Number: 1634391 UDI: 10809160439708 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3005-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.