FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard HEAD AND NECK TRAY recalled for incomplete header bag seal
What this means
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
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
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 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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