Recall Z-1338-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
| Date | Feb 9, 2026 (initiated Jan 2, 2026) |
| Status | Open, Classified |
| Reason | Tyvek bag seal issue which may compromise sterility of the kit. |
| Root cause | Equipment maintenance |
| Action | AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed. |
| Quantity | 1,500 units |
| Distribution | US Nationwide distribution in the states of New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.