FDA-Device2026-02-18Class IIPACKAGING DEFECT
Halyard TRANSPORT BAG KIT recalled for potential sterility compromise due to Tyvek seal defect
What this means
Halyard TRANSPORT BAG KIT (Kit Code LIFE0080-01) may have a defective Tyvek bag seal that could compromise the sterility of the kit. The issue affects approximately 1,500 units distributed in New Jersey. No injuries have been reported.
- Stop using the affected kit immediately if you have Lot Number 1650056 (Expiration 07/24/2028)
- Contact your supplier or Halyard for instructions on return or replacement
- Do not use the kit for transport if the seal appears compromised or damaged
The agency's original wording
Hazard
Tyvek bag seal issue which may compromise sterility of the kit.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of New Jersey.
Affected count
1,500 units
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2026More 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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