HIGH

Medline Recalls Urology Kits Over Leak and Vapor Risks

Medline recalled 12 medical procedure kits on December 16, 2025, due to leaking issues. The kits contain Stryker's Strykeflow 2 Suction Irrigators, which can emit vaporized saline resembling smoke. Patients and healthcare providers must stop using these devices immediately.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

  1. Check the model numbers on the kit packaging.
  2. Verify if your product is labeled as KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
BURNELECTRICAL

Product Classification

Product Details

Model Numbers
UDI/DI 10198459156991 (EA) 40198459156992 (CS)
Lot Number 25EBM426
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Medline NAMIC RA Syringe Adaptor Recall Aims to Prevent Connection Failures in 60 Kits (2026)

Medline Industries, LP recalled 60 medical convenience kits worldwide due to a potential rotating adaptor unwinding in NAMIC Angiographic RA control syringes. The issue may cause a loose connection or disconnection between the syringe and manifold. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Rotating Adaptor Syringe Recall Affects 762 Units Worldwide (2026)

Medline Industries, LP recalls 762 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes sold worldwide, including the U.S., PR, Canada, and several international markets. The recall cites a potential risk that the syringe rotating adaptor may unwind during use, creating a loose connection or disconnect between the syringe and the manifold. Stop using the device and seek

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Syringe Recall Affects 17,902 Kits Worldwide (2026)

Medline Industries, LP recalls 17,902 medical convenience kits worldwide after post-market surveillance found a potential risk of the syringe rotating adaptor unwinding. The recall covers NAMIC Angiographic RA control syringes labeled in 10 Medline SKUs. Healthcare providers should stop use immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Rotating Adaptor Syringes Recalled in Class I Action for 79,843 Units

Medline Industries issued a Class I recall for 79,843 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes. The action covers worldwide distribution including the US and PR. The risk is a syringe adaptor unwinding during use, which may cause a loose connection or disconnection with the manifold. Stop using the device immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline Angiography Kit Recall: 3,120 Medical Convenience Kits With NAMIC Adaptor May Disconnect (Z-

Medline Industries, LP recalls 3,120 medical convenience kits worldwide due to a risk the syringe rotating adaptor may unwind during use. The issue can create a loose connection or complete disconnection between the syringe and manifold. The recall was issued on February 27, 2026 and is active. Customers should stop using the kit and follow manufacturer instructions for recall notices.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic RA Syringes Recalled in 1698 Kits for Unwinding Adaptor Risk (2026)

Medline Industries, LP recalls 1,698 medical convenience kits worldwide over a potential unwind of the NAMIC Angiographic Rotating Adaptor during use. The risk could cause a loose connection or complete disconnection between the syringe and manifold. Healthcare providers and patients should stop using the affected kits immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more