Z-2964-2026Class II

Halyard LAVH PACK, Model/Catalog Number: USAR053-11

Name: Z-2964-2026 Halyard LAVH PACK, Model/Catalog Number: USAR053-11
Creator: AVID Medical, Inc.
Published: 2026-07-10
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-07-10 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard LAVH PACK, Model/Catalog Number: USAR053-11 on 2026-07-10. FDA classified it as Class II and gives the reason as "A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in...". 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-2964-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-10
Posted: 2026-08-14
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard LAVH PACK, Model/Catalog Number: USAR053-11
Product code: OKV Obstetrical Kit
Reason for recall: A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 7/10/2026 via email. The notice explained the issue, potential risks to health, and requested the following: "ACTIONS TO TAKE: " DO NOT USE AND DISCARD the Clearify Visualization System (Component# 5303907) located in the convenience kit identified in Table 1 above. All other components in the kits may continue to be used. " Add warning labels to affected AVID kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Please contact your Sales Representative if pre-printed labels are needed. " Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " Complete the attached Recall Response Form and return by July 22, 2026."
Quantity in commerce: 40 packs
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2964-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2964-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code OKV

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)