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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Urology Convenience Kits
- Model numbers
- 1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085, 2) DYKMBNDL106, Lot Number: 21ABJ542, 3) DYKMBNDL106A, UDI-DI: 10193489880816(each) +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Locate the model number on the product packaging or instruction manual.
- Check the lot numbers against the recall information provided by Medline.
- 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.
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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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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