Medline recalls 40+ convenience kits for eye and surgical use due to potential calibration issues during sterilization that could impact 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 40 different convenience kits used in eye and surgical procedures because calibration problems during sterilization might compromise their sterility. This means the kits could be contaminated and pose infection risks during medical procedures.
The equipment used to sterilize and package these kits had calibration issues that could impact the sterility assurance level. This means the kits might not be properly sterilized and could lead to infections during medical procedures.
Healthcare professionals using these kits for eye or surgical procedures are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check for model numbers like DYKMBNDL104, DYKMBNDL104A, DYKMBNDL159, and others listed in the recall notice. Also check the lot numbers provided for each model.
Identify your kit's model number and lot number by checking the packaging or product label.
If you have the recalled kit, contact Medline directly for instructions on how to return or replace it.
The recall indicates potential calibration issues that could affect sterility, so they should not be used until replaced.
Check the model number and lot number against the list provided in the recall notice.
Contact Medline directly for instructions on returning or replacing the kit.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2113-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2113-2026 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.
