Medline recalls 100+ convenience kits for potential sterility issues from calibration errors during sterilization. Products include major and minor laparotomy kits with specific model numbers and lot numbers. Consumers should check their kits against the list to ensure safety.
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 for potential sterility risks due to calibration issues in sterilization equipment. These kits could be contaminated if used in medical procedures, but the recall does not specify a direct injury risk or remedy.
The calibration issues in the sterilization equipment could lead to reduced sterility assurance levels (SAL) in the kits. This means the kits might not be properly sterilized, potentially causing infections during medical procedures.
Healthcare professionals and facilities using Medline convenience kits for surgical procedures are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check if your kit has a model number starting with CDS860015U, CDS860015V, CDS860015W, CDS860015X, CDS860016P, CDS860016Q, CDS860016R, CDS860016S, or CDS860146M. Also check the lot number listed in the recall notice.
Verify your kit's model number and lot number against the list provided in the recall notice to confirm if it is affected.
Medline identified calibration issues in the sterilization equipment used to package the kits, which could impact the sterility assurance level.
No action is needed if your kit's model and lot numbers do not match those listed in the recall notice.
The recall states potential sterility issues but does not specify a direct injury risk or remedy, so the danger level is unknown.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2098-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2098-2026 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.
