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 listed 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 in their sterilization process might compromise sterility. This means the kits could be contaminated, posing a risk of infection during medical procedures.
The sterilization equipment used to package the kits had calibration issues, which might lead to reduced sterility assurance. This means the kits could be contaminated, increasing the risk of infection during medical procedures.
Healthcare professionals using these kits for endoscopy procedures are most at risk. Patients receiving procedures with these kits could face infection if the kits are not sterile.
Check for model numbers DYKE1455B or DYKE1721. Look for lot numbers listed in the recall: 22IBV801, 21BBK795, 21CBH534, 21CBH946, 21IBL687, 21KBP287, 22EMH737, 22EMI534, 22FMD365, 22FMH954, 22GMH729, 22HMD809, 22JMC784, 22LMF786, 23BMC768, 23CMB706, 23CMC558, 23CMG332, 23EMF635, 23GMC067, 23GMF416, 23HMG566, 23IMF495, 23KMC417.
Identify if your kit has model numbers DYKE1455B or DYKE1721.
Check the lot number on the kit to see if it matches the listed numbers in the recall.
Medline identified calibration issues in the sterilization equipment that could impact the sterility assurance level of the kits.
The affected kits are Baptist Floyd Endo GI Kit (model DYKE1455B) and GI Lab Other Endo Kit (model DYKE1721).
Check for model numbers DYKE1455B or DYKE1721 and lot numbers listed in the recall (e.g., 22IBV801, 21BBK795, etc.).
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2117-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2117-2026 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.
