Medline recalls two convenience kits due to potential sterility risks from calibration problems during sterilization. Affected products include specific models and lot numbers. Consumers should check their items and contact Medline for details.
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 two types of convenience kits because calibration issues during sterilization could compromise their sterility. This means the kits might not be clean enough for medical use, which is dangerous for patients.
The calibration problems during sterilization might lead to the kits not meeting sterility standards. This means the kits could be contaminated and cause infections during medical procedures.
Healthcare workers using these kits for medical procedures are most at risk. Patients receiving treatments with these kits could face infection risks if the kits are not sterile.
Check for model numbers DM1035 or DYKMBNDL43. Lot numbers include 21BBN221, 22GBN333, 22GBF510, 22EBL039, 22CBU342, 21JBJ253, 21IBJ337, 21DBD662, 21ABO838, and 21ABJ003.
Look for model numbers DM1035 or DYKMBNDL43 on the kit.
Reach out to Medline Industries for specific instructions on whether your kit is affected.
Medline identified calibration issues during sterilization that could impact the sterility assurance level of the kits.
The affected models are LVAD DRIVELINE TRAY (DM1035) and KIT SURG ONC INSERT CENT.VENOU (DYKMBNDL43).
Check for model numbers DM1035 or DYKMBNDL43 and lot numbers listed in the 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-1402-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1402-2026 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.
