Recall Z-2407-2026 ยท OJH Orthopedic Tray
AVID Medical, Inc.
Halyard, Pain Pack. Kit Code: AMPK48-01.
| Date | Jun 11, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. |
| Root cause | Process control |
| Action | AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness. |
| Quantity | 120 kits |
| Distribution | US Nationwide distribution in the state of Iowa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.