FDA-Device2026-09-02Class IIMISBRANDING
Halyard TOTAL JOINT surgical kit recalled for undeclared latex in statlock component
What this means
Halyard TOTAL JOINT surgical kits (Model MSBM036-03) were distributed with incomplete labeling that failed to warn users that the statlock component contains natural rubber latex. This omission creates a risk for patients and healthcare workers with latex allergies. Approximately 120 kits were affected in Mississippi and Texas.
- Check your facility's inventory for Halyard TOTAL JOINT Model MSBM036-03, Lot Number 1662335.
- If found, do not use the kit on patients with known or suspected latex allergy.
- Contact Halyard or your supplier for replacement kits with correct labeling or further instructions.
- Review patient records if this kit was used to identify anyone at risk.
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
120 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-3009-2026More 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.