Recall Z-0929-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
| Date | Dec 15, 2025 (initiated Nov 14, 2025) |
| Status | Open, Classified |
| Reason | Potential for incomplete seal on header bag. |
| Root cause | Nonconforming Material/Component |
| Action | AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form. |
| Quantity | 90 units |
| Distribution | US distribution to GA, IL, NE, MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.