FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Recall number
- Z-0927-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Status
- Open, Classified
- Initiated
- 2025-11-14
- Posted
- 2025-12-15
- Terminated
- not on file
- 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
- 240 units
- Distribution
- US distribution to GA, IL, NE, MD.
- Lot, serial or model codes
- Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28