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Medium risk Medical DevicesClass II

Medline Strykeflow 2 Suction Irrigator Recall

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Updated December 16, 2025

Medline robotics urology prostate kits containing Stryker Strykeflow 2 Suction Irrigators may leak or emit vaporized saline during use due to a 2024 design change that allows irrigation solution to reach the handpiece and battery pack.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on December 16, 2025. Details below.

What is recalled

Medline medical procedure convenience kits labeled as KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G, containing Stryker Strykeflow 2 Suction Irrigators.

Am I affected

You're affected if you have a Medline robotics urology prostate kit (REF DYKMBNDL116G) that contains a Stryker Strykeflow 2 Suction Irrigator purchased or in use in 2024 or later.

What to do right now

Stop using the Strykeflow 2 Suction Irrigator in this kit immediately. Contact Medline Industries for instructions on how to proceed with the recall.

The hazard

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.

Brands affected

Medline Industries, LP
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1090-2026
Classification
Class II
Recalled
December 16, 2025
Read the official notice

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