FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard EP LAB PK sterile field pack recalled for incomplete header bag seal
What this means
AVID Medical is recalling Halyard EP LAB PK sterile field packs (Catalog Number ESJH009-03) because the header bag may not seal completely during sterilization. An incomplete seal could allow bacteria or other contaminants to enter the sterile package before use. This affects 240 units distributed to hospitals and medical facilities in Georgia, Illinois, Nebraska, and Maryland.
- Stop using affected Halyard EP LAB PK packs immediately, especially Lot 1653112
- Check your inventory for Catalog Number ESJH009-03 and UDI-DI 10809160427316
- Contact AVID Medical or your supplier for instructions on safe disposal and replacement
- Review any procedures already performed with packs from this lot
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
240 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2026More 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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