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

Recall date

December 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1090-2026

FDA classification

Class II

Brand / firm

Medline Industries, LP

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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