Z-3005-2026Class II

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK...

Name: Z-3005-2026 Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK...
Creator: AVID Medical, Inc.
Published: 2026-07-09
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-07-09 / Open, Classified / root cause: labeling and UDI

FDA source

AVID Medical, Inc. began a recall of Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27 on 2026-07-09. FDA classified it as Class II and gives the reason as "Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3005-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-09
Posted: 2026-08-21
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Product code: LRO General Surgery Tray
Reason for recall: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On July 9, 2026 Avid Medical ( subsidiary of Owen & Minor) issued a Urgent: Medical Device correction notification to affected consignees. Avid Medical ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 2. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Complete the attached Recall Response Form and return by July 24, 2026.
Quantity in commerce: 45 kits
Distribution: US Nationwide distribution in the states of MS, TX.
Product codes and lots: Lot Code: Lot Number: 1634391 UDI: 10809160439708

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3005-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3005-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3006-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3007-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3008-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3009-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3010-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3011-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)