WhichRecall
Class IIReported 2026-01-21

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

Recalled by Medline Industries, LP

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

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This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Recall Number
Z-1090-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-16
Reported
2026-01-21
Distribution
US Nationwide distribution.
Code Info
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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