Medline Industries recalled 96 medical procedure convenience kits on December 16, 2025. The recall affects kits containing Stryker's Strykeflow 2 Suction Irrigators due to a design flaw causing leaks. Patients and healthcare providers must stop using these kits 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 recall includes the following models: 1) THORACIC ROBOTICS, REF DYNJ908777B and 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359. The kits were distributed nationwide in the United States.
The Strykeflow 2 Suction Irrigator may leak saline solution during use, which can travel to the handpiece and battery pack. This could lead to vaporized saline emission that resembles smoke.
No specific incidents or injuries have been reported to date. The hazard presents a high risk of electrical malfunction and potential burns.
Stop using the affected devices immediately. Follow the recall instructions provided by Medline and contact your healthcare provider for further guidance.
For more information, contact Medline Industries, LP at their customer service number or visit the recall notice on the FDA website.
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