FDA-Device2026-10-22Class IIPACKAGING DEFECT
Halyard ANTERIOR HIP PACK surgical kit recalled for non-sterile component
What this means
Halyard ANTERIOR HIP PACK surgical kits (Model SOAH30) contain a component that was not properly sterilized before packaging. The component was placed outside the sterile barrier and did not receive the required sterilization process. This affects 80 kits with lot numbers 1705826 and 1705827, expiring 1/31/2028.
- Check if you have affected kits by looking for Model SOAH30 with lot numbers 1705826 or 1705827.
- Do not use the affected kits for surgery.
- Contact your healthcare facility's materials management or Halyard Medical for instructions on return or disposal.
- Report any patient exposure or adverse events to the FDA.
The agency's original wording
Hazard
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distributor in the state of Arizona.
Affected count
80 kits
Manufactured in
9000 Westmont Dr, Toano, Virginia, United States
Products
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0283-2027More AVID Medical recalls
- FDA-Device2026-10-22Halyard ANTERIOR HIP PACK (SOAH31) recalled for non-sterile component
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- FDA-Device2026-10-14AVID Medical HEART PREP TRAY recalled for potential manufacturing lubricant contamination
- FDA-Device2026-10-14AVID Medical PACK OPEN HEART CFH recalled for potential manufacturing lubricant contamination
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