FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard Major Pack surgical kit recalled for incomplete header bag seal
Stop using Halyard Major Pack surgical kits
AVID Medical is recalling Halyard Major Pack surgical kits (Catalog Number JEMJ10-01) because the header bag seal may not close completely. This affects 90 units distributed to Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.
- Check if you have Halyard Major Pack (Catalog JEMJ10-01, Lot 1635770, expiration 7/26/2027)
- Do not use affected kits
- Contact your supplier or AVID Medical for instructions on return or replacement
Hazard
Potential for incomplete seal on header bag.
Sold states
US distribution to GA, IL, NE, MD.
Affected count
90 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2026More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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