FDAFDA · Food and drugs·Recall number Z-1090-2026
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Published January 21, 2026 · Recall initiated: December 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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