Medline recalls 34 convenience kits for potential sterility issues due to calibration problems during sterilization. Products include eye, breast, and cataract kits with specific model numbers and lot numbers. Affected items may not be sterile, risking infection during medical procedures.
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 34 different convenience kits used in eye and surgical procedures because calibration issues during sterilization could compromise sterility. This means the kits might not be sterile, increasing infection risk during medical treatments.
The calibration issues in the sterilization equipment used to package these kits could lead to a failure in the sterility assurance level (SAL). This means the kits might not be sterile after packaging, potentially causing infections during medical procedures.
Healthcare professionals using these kits for eye or surgical procedures are most at risk. Patients receiving treatments with these kits could face infection if the kits are not properly sterile.
Check for model numbers like DYKMBNDL104, DYKMBNDL104A, DYNJ17219C, or DYNJ42043I on the product packaging. Lot numbers from 21ABP706 to 23LBJ481 are also associated with affected items.
Look for model numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
The recall states that the kits may not be sterile due to calibration issues, so they should not be used until the recall is addressed.
Check the model number and lot number on the kit. Affected kits have specific model numbers like DYKMBNDL104 and lot numbers from 21ABP706 to 23LBJ481.
The recall does not specify a remedy, so contact Medline directly for guidance on next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1420-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1420-2026 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.
