Medline recalls 359 convenience kits for potential sterility issues due to calibration problems during sterilization. Products include spinal, hip, knee, and joint kits with specific model numbers and lot numbers. No remedy is listed in the recall notice.
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 over 350 convenience kits for potential sterility issues. The problem involves calibration issues during the sterilization process that could affect the sterility assurance level of the products. This means the kits might not be sterile as intended, which is a risk for medical procedures.
The calibration issues during sterilization could lead to a potential failure in the sterility assurance level (SAL) of the products. This means the kits might not be sterile as required for medical procedures, increasing the risk of infection or contamination during surgery.
Healthcare professionals and medical facilities that use these convenience kits for surgical procedures. The risk is primarily for procedures where sterility is critical, but the recall does not indicate immediate injury risk.
Check the model numbers listed in the recall (e.g., CDS940087AG, CDS980832Q) and lot numbers (e.g., 21EBC900) on the product packaging. The recall covers specific kits used in spinal, hip, knee, and joint procedures.
Look for the model number and lot number on the product packaging to confirm if it is in the recall list.
The recall indicates a potential issue with sterility assurance, but no immediate injury risk is mentioned. The kits may not be sterile as intended, which could lead to infection during procedures.
Check the model number and lot number on the product packaging. The recall includes specific kits with model numbers like CDS940087AG and lot numbers such as 21EBC900.
The recall does not specify a remedy, so you should contact Medline directly for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1421-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1421-2026 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.
