Halyard ENT Pack (AVID Medical) – seal compromise (2025)
Hazard assessment based on recall description.
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, ENT PACK. Model Number: JACK421-04. Convenience kit.
Brand
AVID Medical, Inc.
Lot Codes / Batch Numbers
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
Products Sold
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
AVID Medical, Inc. is recalling Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. due to Potential for open header bag seals, compromising sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for open header bag seals, compromising sterility.
Recommended Action
Per FDA guidance
Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.
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 noticePage updated: Jan 10, 2026