Z-0282-2027Class II

Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31

Name: Z-0282-2027 Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31
Creator: AVID Medical, Inc.
Published: 2026-09-08
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-09-08 / Open, Classified

FDA source

Recall record

Recall number: Z-0282-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-09-08
Posted: 2026-10-22
Recalling firm: AVID Medical, Inc.
Product: Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Product code: LRO General Surgery Tray
Reason for recall: A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
FDA root cause: Process control
Action: AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to identify, segregate, and quarantine all impacted kits identified, and to not use the impacted component located in the piggybacked portion of the convenience kit. Customers were also instructed to add warning labels to affected kits to ensure all users are aware of the actions to remove and discard the impacted component prior to use. distributors were instructed to notify consignees if affected units were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.
Quantity in commerce: 56 kits
Distribution: US Nationwide distributor in the state of Arizona.
Product codes and lots: Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0282-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-28	2026-10-22
Z-0283-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-28	2026-10-22

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-27. View this recall on fda.gov (opens on fda.gov)