FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Recall number
- Z-2530-2025
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Status
- Open, Classified
- Initiated
- 2025-08-04
- Posted
- 2025-09-05
- Terminated
- not on file
- Reason
- Potential for open header bag seals, compromising sterility.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 57 units
- Distribution
- US Nationwide distribution in the state of Florida.
- Lot, serial or model codes
- Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
- 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