Medline recalls 100+ convenience kits for spinal, hip, knee procedures due to potential calibration issues affecting sterility. Products may not meet required sterility standards after sterilization.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling over 100 convenience kits used for spinal, hip, and knee procedures because calibration issues during sterilization could compromise their sterility. This means the products might not be sterile as required, which is a risk for infections during medical procedures.
The equipment used to sterilize and package these kits had calibration issues. This could mean the kits weren't properly sterilized, potentially leading to contamination and infection risks during medical procedures.
Healthcare professionals using these kits in medical procedures are most at risk. The recall affects specific model numbers and lot numbers listed in the official notice.
Check for model numbers like CDS940087AG, CDS980832Q, or CDS980833Q and lot numbers starting with 21, 22, or 23. The kits are used in spinal, hip, and knee procedures.
Look for model numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
Reach out to Medline directly for assistance with the recall and to confirm if your specific kit is affected.
Medline identified calibration issues in the equipment used to sterilize and package these kits, which could impact the sterility assurance level.
The recall indicates there is a potential risk that the kits may not meet sterility standards after sterilization, so they should not be used until confirmed safe.
Check the model number and lot number on your kit against the list provided in the official recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2114-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2114-2026 from Medline. 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.
