HIGH

Medline Recalls Urology Kits Over Sterility Issues

Medline Industries recalled 59 urology convenience kits on January 7, 2026, due to sterilization calibration issues. These defects may compromise the sterility assurance level of the devices. Patients and healthcare providers should immediately stop using these products and follow recall instructions.

Quick Facts at a Glance

Recall Date
January 7, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Medline Urology Convenience Kits are designed for use in urological procedures, providing essential tools and equipment for healthcare providers. These kits are often used in clinical settings where sterility is critical for patient safety.

Why This Is Dangerous

Calibration issues with the sterilization equipment may result in products that are not adequately sterilized, increasing the risk of infection for patients. This could pose serious health risks, especially in urological procedures where sterility is paramount.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers using these recalled kits may face serious health risks due to potential infections. The urgency to stop using the devices is critical to ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the product packaging or instruction manual.
  2. Check the lot numbers against the recall information provided by Medline.
  3. If your kit matches any of the recalled models or lot numbers, stop using it immediately.

Where to find product info

Model numbers and lot numbers are typically found on the packaging or labeling of the product.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Follow up with Medline Industries directly via phone or email.
  • Consider contacting consumer protection agencies for assistance.

How to prevent similar issues

  • Always check for recalls before using medical devices.
  • Look for certifications indicating proper sterilization practices when purchasing medical devices.

Documentation advice

Keep records of your purchase, including receipts and communication with Medline regarding the recall.

Product Details

The recall includes the following model numbers: DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, DYKMBNDL189A. These kits were distributed worldwide, including the United States, and were sold through multiple retailers.

Key Facts

  • 59 urology convenience kits recalled
  • Calibration issues affect sterility assurance
  • Immediate stop-use instruction issued
  • No injuries reported
  • Contact Medline for further instructions
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeUrology Convenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) DYKMBNDL106
UDI-DI: 10193489479294(each)
40193489479295(case)
Lot Number: 21BBG085
2) DYKMBNDL106
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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