FDAHealthDecember 16, 2025
Medline Industries, LP — Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 16, 2025
US Nationwide distribution.
What's affected?
- Product
- Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
- Lot code
- 25EBM426
Additional details
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12 units.
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