FDA-Device2026-07-22Class IIPACKAGING DEFECT
Medline Total Knee Pack surgical kits recalled for sterility seal defects
Nationwide distribution
Medline Total Knee Pack kits recalled for seal defects
Medline surgical kits containing Zimmer Biomet mixing bowls and spatulas have a seal defect that could compromise sterility. This defect could require surgeons to find an alternative device during a procedure. No injuries have been reported.
- If your facility received affected kits (Lots 26DMB644 or 26CMC467), do not use them.
- Contact Medline Industries for instructions on return or replacement.
- Check your inventory against the lot numbers listed in this recall.
Hazard
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Sold states
US Nationwide distribution in the states of CA and UT.
Affected count
163 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2026More Medline Industries, LP recalls
- FDA-Device2026-07-22Medline Total Knee Pack recalled for seal defects risking sterility breach
- FDA-Device2026-07-08Medline Convenience kits recalled for defective Swan-Ganz catheters with leak and breakage risk
- FDA-Device2026-07-08Medline Convenience kits recalled for defective Swan-Ganz catheters with leak risk
- FDA-Device2026-07-08Medline surgical and procedure kits recalled for lidocaine ampule quality issues
- FDA-Device2026-07-08Medline Convenience Kits recalled for contaminated lidocaine ampules
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