Class II — AVID Medical, Inc.
| Recalling firm | AVID Medical, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. |
| Product | Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27 |
| Quantity | 45 kits |
| Distribution | US Nationwide distribution in the states of MS, TX. |
| Initiated | 2026-07-09 |
| Classified | 2026-08-21 |
| Recall number | Z-3005-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AVID Medical, Inc. (Z-3005-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99527/
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