Medline recalls non-sterile procedural trays labeled as Total Knee Kit that may have sterile blades causing sterile packaging breaches. Affected units include specific lot numbers and item codes.
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Medline is recalling non-sterile procedural trays labeled as Total Knee Kit because sterile blades inside could puncture the outer foil layer, breaking the sterile packaging. This risk could lead to infections if the kit is used without proper sterility.
Sterile blades inside non-sterile trays can puncture the foil layer, creating a breach in the sterile packaging. This breach could allow contamination and increase infection risk during surgery.
Healthcare professionals using these trays for surgical procedures are most at risk. Patients receiving surgery with these kits could face infection if the sterile packaging is compromised.
Check for trays labeled 'TOTAL KNEE KIT' with item number DYNJ904310F. Look for lot number 22IBD724 or UDI/GTIN case number 40195327116188.
Look for trays labeled 'TOTAL KNEE KIT' with item number DYNJ904310F.
Sterile blades inside non-sterile trays could puncture the foil layer, breaking the sterile packaging and increasing infection risk during surgery.
Check for trays labeled 'TOTAL KNEE KIT' with item number DYNJ904310F, lot number 22IBD724, or UDI/GTIN case number 40195327116188.
The recall does not require immediate stop use; healthcare professionals should check labels and follow the provided steps to ensure safety.
We’ve drafted a message you can send Medline Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-1035-2023 — Medline Industries Medline Industries Hello, I own a Medline Industries that is covered by recall Z-1035-2023 from Medline Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
