Medline recalls three convenience kits due to potential contamination from sterilization calibration issues. Products 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 three types of convenience kits because their sterilization process might not be working correctly. This could mean the kits aren't sterile, which is dangerous for medical use.
The sterilization equipment calibration issues might cause the kits to not be properly sterilized. This could lead to contamination and infection risks during medical procedures.
Healthcare workers using these kits for medical procedures are most at risk. Patients receiving treatments with these kits could be exposed to infections.
Check for model numbers DYNJ15668R, DYNJ42829B, or DYNJT3437. Products were sold with specific lot numbers: 23HMB037, 22IBI084, or 25FBK633.
Look for model numbers DYNJ15668R, DYNJ42829B, or DYNJT3437 on the kit packaging.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The kits may not be sterile due to potential sterilization calibration issues, so they should not be used until the recall is addressed.
Check the model number and lot number on the kit packaging to see if it's affected. If it is, stop using it and contact Medline for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2120-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2120-2026 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.