FDA-Device2026-08-26Class IIPROCESSING DEFECT
Halyard LAVH PACK surgical kit recalled for potential component leaking due to improper sterilization
What this means
Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.
- If you received Halyard LAVH PACK Model USAR053-11 with Lot No. 1669869, do not use the kit.
- Contact your supplier or Halyard Medical for instructions on return or replacement.
- Contact the FDA or report any injuries or complications to the manufacturer immediately.
The agency's original wording
Hazard
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of TX.
Affected count
40 packs
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2964-2026More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
- FDA-Device2026-09-23AVID Medical Haylard Continuous Nerve Block Tray recalled for sterility and quality issues
- FDA-Device2026-09-23Halyard IV START KIT NON-STERILE recalled for fungal contamination in applicators
- FDA-Device2026-09-23Haylard BASIC BIOPSY TRAY (Model PM415) recalled for sterility issues in sodium chloride ampules
- FDA-Device2026-09-23AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
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