Medline recalls 36 convenience kits for potential sterility issues due to calibration problems in sterilization packaging. Affected kits include Angio Procedure Packs and Endo Kits with specific model numbers and lot dates.
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 36 different convenience kits that may have calibration issues during sterilization, which could compromise their sterility. This means the kits might not be sterile when used in medical procedures, posing a risk of infection.
The calibration issues in the sterilization and packaging cycles could lead to a failure in ensuring the kits remain sterile. This means the kits might not meet the required sterility standards, increasing the risk of infection during medical procedures.
Healthcare professionals who use these kits in medical procedures are most at risk. Patients using these kits during surgery or procedures could be exposed to infection if the kits are not properly sterile.
Check for model numbers listed in the recall: ANGIO PROCEDURE PACK (00-401824AA, DYNJ32328), ENDO KIT W/SYRINGE (DYKE1743), and others with specific lot numbers like 23ABN008 through 23BBT999.
Identify the model number and lot number on the kit to confirm if it is affected by this recall.
Reach out to Medline directly for further assistance with the recall process.
Medline identified calibration issues in the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
The affected models include ANGIO PROCEDURE PACK (00-401824AA, DYNJ32328), ENDO KIT W/SYRINGE (DYKE1743), and others with specific lot numbers listed in the recall.
The recall does not require immediate discontinuation; healthcare professionals should check the model and lot numbers and contact Medline for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2091-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2091-2026 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.
