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 contain a statlock component made with natural rubber latex, but the product labeling does not warn of this. People with latex allergies could have a serious allergic reaction if exposed during use.
- If you have this kit (Model MSBM036-03, Lot 1673233), do not use it.
- Check the labeling for the lot number and UDI code listed above.
- If you have a latex allergy, inform your healthcare provider before any procedure using this kit.
- Contact Halyard or your supplier for a replacement kit or 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
130 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-3010-2026More AVID Medical recalls
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