Medline recalls 358 surgical products including GYN Laparoscopy CDS and Robotic Surgery CDS models due to calibration issues that could impact 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 358 surgical products including GYN Laparoscopy CDS and Robotic Surgery CDS models because calibration issues may affect the sterility assurance level during sterilization cycles. This means the products could become contaminated after being sterilized.
The calibration issues in the sterilization and packaging equipment could lead to products not meeting the required sterility assurance level after being processed through validated sterilization cycles. This means the products might become contaminated during use.
Healthcare professionals who use these surgical products in medical procedures are most at risk. The recall affects products used in gynecological and robotic surgery settings.
Check for model numbers like CDS981504G, CDS982407P, CDS982893I, and other specific product codes listed in the recall. Products were sold with specific lot numbers and UDI-DI identifiers.
Review the model numbers and lot numbers listed in the recall to confirm if your product is affected.
Reach out to Medline directly for assistance with the recall process or to confirm product status.
The recall indicates potential issues with sterility assurance, so products may not be safe to use as intended. Contact Medline for specific guidance.
Check the model numbers and lot numbers listed in the recall notice, which includes specific product codes like CDS981504G and DYKM1657A.
Contact Medline directly for instructions on how to handle the product, as the recall does not specify a replacement or disposal process.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2109-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2109-2026 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.
