FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Recall number
- Z-3010-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Status
- Open, Classified
- Initiated
- 2026-07-09
- Posted
- 2026-08-21
- Terminated
- not on file
- Reason
- Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 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
- 130 KITS
- Distribution
- US Nationwide distribution in the states of MS, TX.
- Lot, serial or model codes
- Lot Code: Lot Number: 1673233 UDI: 10809160457887
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28