Medline recalls specific endoscopy kits due to potential calibration issues that could impact sterility assurance levels. Affected kits include Baptist Floyd Endo GI Kit (DYKE1455B) and GI Lab Other Endo Kit (DYKE1721) with various lot numbers.
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 two types of endoscopy kits because calibration problems during sterilization might compromise their sterility. This means the kits could be contaminated, posing a risk of infection for medical procedures.
The calibration issues in the sterilization equipment could lead to a failure in the sterility assurance process. This means the kits might not be properly sterilized, increasing the risk of contamination and infection during medical procedures.
Healthcare professionals using these kits for endoscopy procedures are most at risk. Patients undergoing procedures with these kits could face infection if the kits are not sterile.
Check for model numbers DYKE1455B or DYKE1721 on the kits. Look for lot numbers listed in the recall: 22IBV801 through 23CMB706 for DYKE1721 and 22IBV801 for DYKE1455B.
Look for model numbers DYKE1455B or DYKE1721 on the kits.
Check if the lot number matches those listed in the recall (22IBV801 through 23CMB706 for DYKE1721 and 22IBV801 for DYKE1455B).
Medline identified calibration issues in the sterilization equipment used for these kits, which could impact the sterility assurance level.
The kits may not be sterile due to potential calibration issues, so they should not be used until the recall is addressed.
Check the model number (DYKE1455B or DYKE1721) and lot number against the list provided in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1396-2026 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.
