Medline recalls 131 convenience kits for robotic surgery and gynecology procedures due to potential calibration issues affecting sterility assurance levels. Products were sterilized but may not meet required sterility standards.
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 131 different convenience kits used in robotic surgery and gynecology procedures because calibration issues during sterilization could compromise sterility. These kits are used in medical settings and may not be sterile enough for patient safety.
The calibration issues during sterilization could lead to products not meeting the required sterility standards. This means the kits might not be sterile enough for medical procedures, potentially causing infections or other complications.
Healthcare facilities using these kits for robotic surgery or gynecology procedures are most at risk. Patients using these kits during medical procedures may be exposed to non-sterile items.
Check for the model numbers listed in the recall (e.g., CDS982407N, DYNJ04135B) and lot numbers (e.g., 21DBO201) on the product packaging or labels.
Look for model numbers and lot numbers on the product packaging to confirm if it's in the recall list.
The recall states that the calibration issues may impact sterility assurance levels, so these kits are not recommended for use until the recall is addressed.
Check the model numbers and lot numbers listed in the recall notice to see if your kit matches one of the 131 products identified.
The recall does not specify a remedy, so contact Medline directly for guidance on next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1419-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1419-2026 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.
