Medline recalled 4,536 medical procedure kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. The recall affects various models used in surgeries nationwide.
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 33 models of medical procedure convenience kits, including WCH BARI-GASTRECTOMY and ROBOTIC PROCEDURE kits. These kits were distributed nationwide in the U.S. and contain the Strykeflow 2 Suction Irrigator.
A design change in the Strykeflow 2 Suction Irrigator allows irrigation solution to reach the handpiece and battery pack. This has led to some devices leaking and emitting vaporized saline that resembles smoke.
There have been no specific reports of injuries, but the potential for harm exists due to the leaking and vapor emissions.
Patients and healthcare providers must stop using the affected kits immediately. Follow the manufacturer’s recall instructions and contact Medline Industries, LP for further information.
Contact Medline Industries, LP for more details at 1-800-633-5463 or visit their website for recall instructions.
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