Recall Z-3008-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
| Date | Aug 21, 2026 (initiated Jul 9, 2026) |
| Status | Open, Classified |
| 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 distributo |
| Quantity | 78 kits |
| Distribution | US Nationwide distribution in the states of MS, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.