FDA-Device2026-09-02Class IIMISBRANDING
Halyard TOTAL JOINT surgical kit recalled for undisclosed latex in statlock component
What this means
Halyard TOTAL JOINT surgical kits (Model MSBM036-03, Lot 1649519) were distributed with labeling that failed to identify that the statlock component contains natural rubber latex. Patients or healthcare workers with latex allergies could face a serious allergic reaction if exposed.
- If you have this kit, do not use it and contact Halyard or your healthcare provider immediately.
- Check your inventory for Lot Number 1649519 and Model MSBM036-03.
- Return unused kits to your supplier or contact Halyard for instructions.
The agency's original wording
Hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MS, TX.
Affected count
78 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3011-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.