Medline recalls 96 convenience kits for potential sterility issues due to calibration errors in sterilization packaging. Products include PICC line trays, code carts, and other medical kits with specific model numbers and 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 96 different medical convenience kits that may have calibration issues affecting their sterility assurance level. This means the kits could be contaminated during sterilization, posing a risk of infection for patients.
The recall is due to calibration issues in the sterilization equipment used to package the kits. This could lead to reduced sterility assurance levels, meaning the kits might not be properly sterilized and could cause infections.
Healthcare professionals and medical facilities that use these kits for patient care are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check the model number and lot number on the kit. The recall includes 96 specific model numbers like PICC line trays (00-401993O), code carts (ACC010268B), and other kits with detailed lot numbers.
Look for the model number and lot number on the kit to confirm if it's in the recall list.
The recall states that the kits may have calibration issues affecting sterility, so they should not be used until confirmed safe.
Check the model number and lot number against the list provided in the recall notice.
The recall does not specify a remedy, so contact Medline directly 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-2094-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2094-2026 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.