Medline recalled 12 medical procedure kits on December 16, 2025, due to leaking issues. The kits contain Stryker's Strykeflow 2 Suction Irrigators, which can emit vaporized saline resembling smoke. Patients and healthcare providers must stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The recalled product is labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G. Medline distributed 12 units nationwide. The affected models include UDI/DI 10198459156991 and Lot Number 25EBM426.
The design change in the Strykeflow 2 Suction Irrigator allows irrigation solution to travel to the handpiece and battery pack. This can lead to leaks and vaporized saline emissions, posing a risk of burns or electrical hazards.
Currently, there are no reported injuries or deaths associated with this recall. However, the potential for vaporized saline resembling smoke raises safety concerns for users.
Stop using the recalled kits immediately. Contact Medline Industries, LP or your healthcare provider for further instructions. A notification letter will be sent to affected parties.
For more information, call Medline Industries, LP at 1-800-233-0462. More details are available on the FDA website.
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