Medline recalls 136 convenience kits for gynecology and surgery use due to calibration issues in sterilization equipment that could impact sterility assurance levels. Products include hysteroscopy kits, laparoscopy packs, and more.
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 136 different convenience kits used in gynecology and surgery procedures because calibration issues in the sterilization equipment might compromise their sterility. This means the kits could be contaminated, posing a risk of infection during medical procedures.
The sterilization equipment used to package these kits had calibration issues that could reduce the sterility assurance level (SAL). This means the kits might not be properly sterilized, increasing the risk of infection during medical procedures.
Healthcare professionals who use these kits for gynecology and surgical procedures are most at risk. The recall affects specific models and lot numbers sold to hospitals and clinics.
Check the model number and lot number on the kit. The recalled products include specific hysteroscopy kits, gynecology packs, and surgical convenience kits with model numbers listed in the recall notice.
Look for the model number and lot number on the kit to confirm if it's recalled. The recall includes 136 specific models with detailed lot numbers.
Medline identified calibration issues in the sterilization equipment used to package these kits, which could impact the sterility assurance level (SAL).
Check the model number and lot number on the kit. The recall includes 136 specific models with detailed lot numbers listed in the notice.
The recall does not specify a remedy, so no action is required beyond checking if your kit is listed.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2111-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2111-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
