Medline Total Knee Pack recalled for seal defects risking sterility breach
Medline Total Knee Pack recalled for sterility breach risk
Medline kits containing Zimmer Biomet mixing bowls and spatulas have seal defects that could compromise sterility during knee replacement surgery. The issue may require surgeons to obtain replacement equipment during the procedure, but no patient injuries have been reported.
- If you received or used kit lot 26DME172 (UDI-DI 10195327388447), contact your surgical facility or Medline for guidance.
- Do not use affected kits for sterile procedures.
- Check with your hospital or surgery center about whether you were affected.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2737-2026More Medline Industries, LP recalls
- FDA-Device2026-07-22Medline Total Knee Pack surgical kits recalled for sterility seal defects
- 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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