Medline recalls 191 convenience kits for obstetrics and labor delivery use due to potential calibration issues affecting sterility assurance levels during sterilization packaging cycles.
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 191 different obstetrics and labor delivery convenience kits because calibration problems in the 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 are packaged, which could lead to infections during medical procedures.
Healthcare providers using these kits for obstetrics and labor delivery procedures are most at risk. The recall affects specific models and lot numbers sold between 2021 and 2025.
Check the model number and lot number on the kit. The recall includes 191 specific models with model numbers like DYKM2326, DYKMBNDL165, and others, along with specific lot numbers listed in the recall notice.
Look for the model number and lot number on the kit to see if it's in the recall list.
The recall states that the kits may not be sterile due to calibration issues in the sterilization equipment, so they should not be used until the recall is addressed.
Check the model number and lot number on the kit. The recall includes 191 specific models with model numbers like DYKM2326, DYKMBNDL165, and others, along with specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so you should contact Medline directly to get advice on how to handle the affected kits.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1414-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1414-2026 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.
