Medline recalls 85 convenience kits for potential sterility issues due to calibration problems in sterilization equipment. All kits were packaged using validated cycles but calibration issues may affect sterility assurance level.
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 85 different medical convenience kits because calibration problems in their sterilization equipment could compromise the sterility of the products. This means the kits might not be sterile when used, which is a serious risk for medical procedures.
The sterilization equipment used to package these kits had calibration issues that could impact the sterility assurance level (SAL). This means the kits might not be sterile when they leave the factory, which could lead to infections during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for procedures like IV lines and central line access. The risk is highest for those handling the kits in sterile environments.
Check for model numbers listed in the recall: 00-401993O, ACC010268B, ACC010268C, ACC010487, CVI3650, DYKM2170, DYKMBNDL153C, DYKMBNDL43A, DYKMBNDL43C, DYNDA2076B, DYNDA2076D, DYNDA2076F, DYNDA2322B, DYNDC2407A, DYNDC2407B, DYNJ40500A, DYNJ42694C, DYNJ53427B, DYNJ55546D, DYNJ63199A, DYNJ70141MB, DYNJ70152MB, DYNJ84239, PICCNC0004. Also check the lot numbers provided in the recall list.
Look for the model numbers listed in the recall to confirm if your kit is affected.
Reach out to Medline directly for assistance with the recall process.
The recall states that the kits may not be sterile due to calibration issues in sterilization equipment, so they should not be used until the recall is addressed.
Check the model numbers listed in the recall: 00-401993O, ACC010268B, ACC010268C, ACC010487, CVI3650, DYKM2170, DYKMBNDL153C, DYKMBNDL43A, DYKMBNDL43C, DYNDA2076B, DYNDA2076D, DYNDA2076F, DYNDA2322B, DYNDC2407A, DYNDC2407B, DYNJ40500A, DYNJ42694C, DYNJ53427B, DYNJ55546D, DYNJ63199A, DYNJ70141MB, DYNJ70152MB, DYNJ84239, PICCNC0004.
Contact Medline directly for instructions on how to handle the recalled kits.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1391-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1391-2026 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.
