Halyard, EP LAB PK. Catalog Number: ESJH009-03. (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)
Incomplete header bag seal may potentially compromise medical kit sterility.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Brand
AVID Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
AVID Medical, Inc. is recalling Halyard, EP LAB PK. Catalog Number: ESJH009-03. due to Potential for incomplete seal on header bag.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for incomplete seal on header bag.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IL, MD, NE
Page updated: Jan 10, 2026