Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
FDA device recall Z-0929-2026 · posted 2025-12-15 · Open, Classified
Recall details
- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Potential for incomplete seal on header bag.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 90 units
- Distribution
- US distribution to GA, IL, NE, MD.
- Date initiated
- 2025-11-14
- Date posted
- 2025-12-15
- Location
- Toano, VA
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