Medline recalls 48 convenience kits for potential sterility issues due to calibration problems in sterilization equipment. Products may not meet sterility standards.
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 48 different convenience kits that were sterilized using equipment with calibration issues. This could mean the kits aren't sterile as they should be, which is risky for medical procedures.
The sterilization equipment used to package these kits had calibration issues. This could mean the kits don't meet the required sterility standards, potentially leading to infections during medical procedures.
Healthcare professionals using these kits for medical procedures are most at risk. The recall affects specific models sold with certain lot numbers.
Check for model numbers: CVI4500A, DYKM1730A, DYKM1751A, DYKM1756A, DYKM1765A, DYKM1767B, DYKM1776, DYKM1781A, DYKM1783A, DYKM1796A, DYKM1801B, DYKM1807, DYKM1864, DYKM1925, DYKM1927A, DYKM1977B, DYKM2131. Look for specific lot numbers listed in the recall notice.
Identify the model number on the kit to see if it's in the recall list.
Reach out to Medline for assistance with the recall process.
Medline identified calibration issues in the sterilization equipment used to package these kits, which could impact the sterility assurance level.
The recall includes 48 specific models with model numbers like CVI4500A, DYKM1730A, and others, each with specific lot numbers.
The recall does not require immediate discontinuation; healthcare professionals should check the model and lot numbers and contact Medline for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2102-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2102-2026 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.