Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Recall Z-3009-2026 · Posted 2026-08-21
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Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-07-09
Product Quantity120 Kits
Reason for Recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of MS, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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