Z-2530-2025Class II

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit

Name: Z-2530-2025 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit
Creator: AVID Medical, Inc.
Published: 2025-08-04
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2025-08-04 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit on 2025-08-04. FDA classified it as Class II and gives the reason as "Potential for open header bag seals, compromising sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2530-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-04
Posted: 2025-09-05
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Product code: LRO General Surgery Tray
Reason for recall: Potential for open header bag seals, compromising sterility.
Root cause tag: manufacturing process
FDA 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 in commerce: 57 units
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2530-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2530-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05
Z-2531-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)