Medline recalls specific medical procedure kits with Strykeflow 2 suction irrigators that may leak saline vapor during use, posing a risk of confusion with smoke. Affected kits have unique labels and lot numbers.
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.
Medline is recalling medical procedure kits labeled 'KIT ROBOTICS UROLOGY PROSTATE' that include Strykeflow 2 Suction Irrigators. The design change in 2:2024 can cause leaks or vaporized saline that may resemble smoke, potentially causing confusion with actual smoke.
The design change in 2024 allows irrigation solution to travel to the handpiece and battery pack during use. This can cause leaks or vaporized saline that may look like smoke, leading to confusion with actual smoke.
Healthcare professionals using these kits for urology procedures are most at risk. Patients using the kits during medical procedures could be affected if the saline vapor is mistaken for smoke.
Look for kits labeled 'KIT ROBOTICS UROLOGY PROSTATE' with reference number DYKMBNDL116G. Lot numbers 25EBM426 or UDI/DI numbers 10198459156991 (EA) and 40198459156992 (CS) indicate affected units.
Verify the kit label for 'KIT ROBOTICS UROLOGY PROSTATE' and reference number DYKMBNDL116G.
Reach out to Medline for guidance on whether your kit is affected and next steps.
The design change in 2024 allows irrigation solution to travel to the handpiece and battery pack, causing leaks or vaporized saline that may resemble smoke.
Check for the label 'KIT ROBOTICS UROLOGY PROSTATE' with reference number DYKMBNDL116G and lot number 25EBM426.
Contact Medline directly to confirm if your kit is affected and get instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1090-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1090-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
