Medline recalls several convenience kits due to potential calibration issues during sterilization that could impact sterility assurance levels. Affected kits include specific models 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 multiple convenience kits because calibration problems in their sterilization process might compromise the sterility of the products. This could lead to infections if the kits are used in medical settings.
The calibration issues in the sterilization equipment could lead to reduced sterility assurance levels. This means the kits might not be properly sterilized, increasing the risk of infection for patients during medical procedures.
Healthcare professionals and medical facilities that use these kits for patient care are most at risk. The recall affects specific models and lot numbers sold to hospitals and clinics.
Check for model numbers DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, or CVI4300. Look for specific lot numbers listed in the recall notice.
Identify the model number and lot number on the kit to confirm if it's affected by this recall.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The affected models include KIT ACES INSERT PEG (DYKMBNDL130 and DYKMBNDL130A), KIT ACES INSERT PERCUTANEOUS T (DYKMBNDL4), NICU LINE CHANGE TRAY (LC295), OSC SHERMAN KNEE ARTHRO BASIC (DYKM1977C), and PICC CATHETER INSERTION TRAY (CVI4300).
Yes, check the model number and lot number on your kit to see if it's 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-1401-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1401-2026 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.
