Medline recalls 75+ convenience kits for potential sterility issues due to calibration problems in sterilization cycles. Products may not meet sterility standards, but no injuries reported. Consumers should check model numbers and lot numbers listed.
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 75 different surgical convenience kits because calibration issues in their sterilization process could lead to products not being sterile. This means the kits might not meet safety standards, but no injuries have been reported yet. Affected products include various laparoscopic and urology kits with specific model numbers and lot numbers.
The calibration issues in the sterilization equipment could cause the kits to not meet sterility assurance levels (SAL). This means the kits might not be sterile when used in surgical procedures, potentially leading to infections or other complications.
Healthcare professionals using Medline's surgical convenience kits are most at risk. Patients using these kits during procedures could be exposed to non-sterile items if the kits were used without proper sterilization.
Check if your kit has a model number listed in the recall (e.g., CDS860015U, CDS982518M) and a lot number from the list provided. The recall includes 75 different model numbers with specific lot numbers.
Look for the model number and lot number on your kit to see if it's in the recall list.
If your kit is recalled, contact Medline directly for instructions on how to return it or get a replacement.
No injuries have been reported as of the recall announcement.
Check the model number and lot number on your kit against the list provided in the recall notice.
Contact Medline directly to return the kit or get a replacement.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1395-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1395-2026 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.
