Medline robotics urology prostate kit with Strykeflow 2 suction irrigator recalled for fluid leakage
What this means
Medline medical procedure kits containing Stryker's Strykeflow 2 Suction Irrigators may leak irrigation fluid into the handpiece and battery pack during use due to a 2024 design change. Some devices have leaked fluid or released vaporized saline that may resemble smoke.
- Stop using the Medline KIT ROBOTICS UROLOGY PROSTATE (REF DYKMBNDL116G) immediately
- Contact Medline for instructions on device return or replacement
- Do not use the device until you receive guidance from Medline or your healthcare provider
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1090-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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