Medline recalls 100+ convenience kits for robotic surgery and gynecology procedures due to calibration issues that could affect sterility assurance levels during sterilization cycles.
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 100 convenience kits used in robotic surgery and gynecology procedures because calibration problems during sterilization might compromise their sterility. This means the kits could be contaminated if used improperly.
The equipment used to sterilize and package these kits had calibration issues that could impact the sterility assurance level (SAL). This means the kits might not be properly sterilized and could become contaminated during use.
Healthcare facilities that use these kits for robotic surgery or gynecology procedures are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check for model numbers like CDS982407N, CDS985431J, or DYNJ04135B, and lot numbers from the list provided in the recall notice. The kits were sold with specific UDI-DI and lot numbers.
Identify your kit's model number and lot number to confirm if it's in the recall list.
Reach out to Medline for guidance on next steps if your kit is affected.
The recall indicates potential sterility issues, so affected kits should not be used until contacted by Medline.
Check the model number and lot number against the list provided in the recall notice.
Contact Medline directly for instructions on how to handle the affected kits.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2112-2026 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.
