Recall Z-0283-2027 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
| Date | Oct 22, 2026 (initiated Sep 8, 2026) |
| Status | Open, Classified |
| Reason | A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. |
| Root cause | Process control |
| Action | AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to identify, segregate, and quarantine all impacted kits identified, and to not use the impacted component located in the piggybacked portion of the convenience kit. Customers were also instructed to add warning labels to affected kits to ensure all users are aware of the actions to remove and discard the impacted component prior to use. distributors were instructed to notify consignees if affected units were further distributed. Additionally, consignees were |
| Quantity | 80 kits |
| Distribution | US Nationwide distributor in the state of Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.