Quick Facts at a Glance
- Recall Date
- December 16, 2025
- 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
- Medical Procedure Convenience Kits
- Model numbers
- UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
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 medical procedure convenience kits are designed for use in urology procedures, providing essential tools and devices for healthcare providers. These kits are critical in ensuring efficient and safe medical interventions.
Why This Is Dangerous
The design flaw allows saline solution to leak into areas of the device not intended for fluid exposure. This can lead to hazardous situations during medical procedures, including potential electrical risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face immediate safety risks while using these kits, which may compromise the quality of care during urological procedures.
Practical Guidance
How to identify if yours is affected
- Check the model numbers on the kit packaging.
- Verify if your product is labeled as KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G.
- Look for Lot Number 25EBM426.
Where to find product info
Serial numbers and lot numbers can typically be found on the product's outer packaging or labeling.
What timeline to expect
Anticipate a refund processing timeline of 4-6 weeks after submitting your request to Medline.
If the manufacturer is unresponsive
- Contact Medline customer service again for updates.
- Document all communications for future reference.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Look for updated designs that have been safety tested before purchasing medical devices.
- Ensure products have certifications from appropriate regulatory bodies.
- Be aware of recalls and product safety notices from manufacturers.
Documentation advice
Keep copies of receipts, correspondence with the manufacturer, and photographs of the product for your records.
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Product Details
The recalled product is labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G. Medline distributed 12 units nationwide. The affected models include UDI/DI 10198459156991 and Lot Number 25EBM426.
Key Facts
- Recall Date: December 16, 2025
- Report Date: January 21, 2026
- Quantity Recalled: 12 units
- Distribution: US Nationwide
- Hazard Level: High
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Safety Guide
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