FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard HEAD AND NECK TRAY recalled for incomplete header bag seal
Stop using Halyard HEAD AND NECK TRAY
AVID Medical is recalling Halyard HEAD AND NECK TRAY (Catalog Number EURO016-09) due to a potential incomplete seal on the header bag. This affects 56 units distributed in Georgia, Illinois, Nebraska, and Maryland. An incomplete seal could compromise the sterility or integrity of the surgical tray.
- Check if you have Halyard HEAD AND NECK TRAY Catalog Number EURO016-09, Lot 1655501
- Do not use the affected tray if you have it
- 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
56 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2026More 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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