Medline recalls convenience kits for lithotomy and lap basin that may not be sterile due to calibration problems in sterilization packaging. Affected products include specific model numbers and 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 and lap basin procedures because calibration issues during sterilization could compromise sterility. This means the products might not be sterile, posing a risk of infection during medical procedures.
The sterilization and packaging cycles used for these kits had calibration issues that could affect the sterility assurance level. This means the kits might not be sterile, increasing the risk of infection during medical procedures.
Healthcare professionals using Medline convenience kits for surgical procedures are most at risk. Patients undergoing lithotomy or laparoscopic surgeries could be exposed to infection if the kits are not properly sterile.
Check for model numbers DYNJ83185, DYNJ83185A, or DYNJVB91109D on the kit. Lot numbers 22LDA486 through 25LLA489 are also affected.
Look for model numbers DYNJ83185, DYNJ83185A, or DYNJVB91109D and lot numbers 22LDA486 through 25LLA489 on the kit.
Medline identified calibration issues in the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
The kits may not be sterile due to calibration problems, so they should not be used until the recall is addressed.
Check the model numbers and lot numbers on the kits to see if they are affected. If they are, 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-2100-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2100-2026 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.