Medline recalls 44 convenience kits for surgical use due to potential calibration issues that could impact sterility assurance levels. Products were sterilized but calibration problems may compromise 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 44 different surgical convenience kits because calibration issues during sterilization could compromise their sterility. This means the kits might not be sterile when used, posing a risk of infection during medical procedures.
The kits were sterilized using validated cycles, but calibration problems with the equipment used for sterilization could lead to reduced sterility assurance levels. This means the kits might not be sterile when used, increasing the risk of infection during medical procedures.
Healthcare professionals and medical facilities that use these kits for surgical procedures. The risk is primarily for those handling the kits during medical operations.
Check for model numbers listed in the recall: DYKMBNDL84A, DYKMBNDL87A, DYNDH1143C, DYNDH1873, DYNDH1934, DYNJ17489I, DYNJ17558D, DYNJ19063K, DYNJ48539, DYNJ48539A, DYNJ59897B, DYNJ82998, DYNJ910654. Also check lot numbers and UDI-DI codes provided in the recall list.
Identify the model number and lot number from the product labels to confirm if it is in the recall list.
Medline has identified calibration issues with the sterilization equipment used for these kits, which could impact the sterility assurance level.
Check the model number and lot number on the product to see if it is in the recall list. If it is, contact Medline for further instructions.
The recall indicates potential risks to sterility, but the kits were previously sterilized. The manufacturer has not provided a specific remedy, so they should be checked for recall status.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2095-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2095-2026 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.
