FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard arteriogram kit recalled for incomplete header bag seal
Stop using Halyard arteriogram kits
AVID Medical is recalling Halyard arteriogram kits (Catalog Number EUHM009-01) because the header bag may not seal completely. This could allow the sterile contents inside to become contaminated. The recall affects 300 units distributed to hospitals in Georgia, Illinois, Nebraska, and Maryland.
- Stop using affected kits immediately if you have them in stock.
- Check your inventory for Catalog Number EUHM009-01, Lot 1635477 (expiration 5/29/2028).
- Contact your supplier or AVID Medical for instructions on return or replacement.
- If you already used a kit from this lot, contact your medical device representative or local health authority.
Hazard
Potential for incomplete seal on header bag.
Sold states
US distribution to GA, IL, NE, MD.
Affected count
300 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2026More 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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