Medline recalls 47 convenience kits for potential sterility issues due to calibration problems in sterilization equipment. Affected kits include specific models and lot numbers. Consumers should check their kits and contact Medline for details.
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 47 convenience kits that may have calibration issues affecting their sterility assurance level. This could lead to contaminated medical devices if used improperly.
The calibration issues in the sterilization equipment used for these kits could impact the sterility assurance level (SAL). This means the kits might not be properly sterilized, potentially leading to contamination if used in medical procedures.
Healthcare professionals and medical facilities using these kits for surgical procedures are most at risk. The recall affects specific models and lot numbers sold between 2020 and 2024.
Check for model numbers DYKM1730A, DYKM1756A, DYKM1765A, DYKM1776, DYKM1781A, DYKM1783A, DYKM1796A, DYKM1801B, DYKM1807, DYKM1925, DYKM1927A, DYKM1977B, and CVI4500A. Look for specific lot numbers listed in the recall notice.
Identify your kit's model number and lot number to see if it's listed in the recall.
Medline identified calibration issues in the sterilization equipment used for these kits, which could impact the sterility assurance level.
Check the model number and lot number on your kit against the list provided in the recall notice.
Contact Medline directly to confirm your kit's status and follow their instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1400-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1400-2026 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.
