Recall Z-0282-2027— AVID Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by AVID Medical, Inc., initiated 2026-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.. Reason: A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications..
- Recalling firm
- AVID Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-08
- Firm location
- Toano, VA, United States
Product description
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.