FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard Major Pack surgical kit recalled for incomplete header bag seal
What this means
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
The agency's original wording
Hazard
Potential for incomplete seal on header bag.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-07-29Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
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