FDA recall Z-0929-2026
AVID Medical, Inc. · Class II · device
Product
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Reason for recall
Potential for incomplete seal on header bag.
Distribution
US distribution to GA, IL, NE, MD.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-11-14
- Report date
- 2025-12-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2026