Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
FDA device recall Z-1338-2026 · posted 2026-02-09 · Open, Classified
Recall details
- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Tyvek bag seal issue which may compromise sterility of the kit.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 1,500 units
- Distribution
- US Nationwide distribution in the states of New Jersey.
- Date initiated
- 2026-01-02
- Date posted
- 2026-02-09
- Location
- Toano, VA
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