Medline recalls convenience kits with potential sterility risks due to calibration issues in sterilization packaging. Affected models include ANCILLARY PACK-LF and OPEN HEART ANESTHESIA ICC-A kits. Check model numbers and lot numbers for affected items.
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 convenience kits that may not be sterile due to calibration problems in the sterilization process. This could lead to infections if the kits are used in medical procedures.
The calibration issues in the sterilization equipment might compromise the sterility assurance level of the kits. This means the kits could be contaminated, increasing the risk of infection during medical procedures.
Healthcare professionals using Medline convenience kits for medical procedures are most at risk. Patients using these kits could face infection if the kits are not properly sterile.
Check for model numbers DYNJ0185290G (ANCILLARY PACK-LF) or DYNJ905567A (OPEN HEART ANESTHESIA ICC-A). Lot numbers 22LBQ336 through 21EBE777 are affected.
Look for model numbers DYNJ0185290G or DYNJ905567A on the kits.
Check if the lot number is between 22LBQ336 and 21EBE777.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The kits may not be sterile, which could lead to infections during medical procedures.
Check the model number and lot number on the kit. Affected models include DYNJ0185290G and DYNJ905567A with lot numbers from 22LBQ336 to 21EBE777.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1384-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1384-2026 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.
