Medline recalls convenience kits for lithotomy procedures due to potential sterility assurance level issues from calibration problems during sterilization. Affected models include DYNJ83185 and DYNJ83185A with specific lot numbers.
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 convenience kits for lithotomy procedures because calibration issues during sterilization could compromise sterility. This means the kits might not be sterile, which is critical for medical procedures.
The calibration issues in the sterilization equipment could lead to a failure in the sterility assurance level. This means the kits might not be sterile after packaging, increasing the risk of infection during medical procedures.
Healthcare professionals using these kits for lithotomy procedures are most at risk. Patients receiving these kits during surgery could be exposed to infection if the kits are not properly sterile.
Check for model numbers DYNJ83185 or DYNJ83185A with specific lot numbers listed in the recall notice. These kits are used in lithotomy procedures and sold by Medline.
Review the model number and lot number on the kit to confirm if it is affected by this recall.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The kits may not be sterile due to potential calibration issues, so they should not be used until the recall is addressed.
Check the model number and lot number to see if it is affected. If it is, contact Medline for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1398-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1398-2026 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.
