Brand Name: Halyard recallZ-3005-2026 · AVID Medical, Inc. · initiated Jul 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-3005-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 9, 2026
- Posted by the FDA
- Aug 21, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 45 kits
- Product code
- LRO
- Distribution
- US Nationwide distribution in the states of MS, TX.
Product description
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Code information (models, lots, serial numbers)
Lot Code: Lot Number: 1634391 UDI: 10809160439708
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard SAMM064-27_0002Avid Medical, Inc. · General surgery tray2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99527).
- Z-3006-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Z-3007-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Z-3008-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Z-3009-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Z-3010-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Z-3011-2026 · Open, ClassifiedHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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