Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1090-2026 — Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

U.S. FDA — Device Enforcement · United States · 2025-12-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1090-2026
Date of alert
2025-12-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10198459156991
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.