Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBN...
FDA Recall #Z-1090-2026 — Class II — December 16, 2025
Product Description
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Reason for Recall
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated