Medline Industries recalled 1,457 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. Healthcare providers and patients must stop using the 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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Medline medical procedure convenience kits are used in various surgical procedures to provide necessary tools and supplies. These kits are essential for healthcare providers to ensure safe and efficient surgeries.
The design change in the Strykeflow 2 allows saline to leak into the handpiece and battery pack, potentially leading to burns when the device is in use. This issue arises during medical procedures, increasing risks for both patients and healthcare professionals.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers' ability to perform certain procedures safely, leading to potential delays in treatment for patients. Immediate action is necessary to prevent injury.
Model numbers and lot numbers can typically be found on the product packaging or the device itself, usually near the barcode or on the product label.
Refund processing may take approximately 4-6 weeks after the return is initiated.
Keep records of all communications with the manufacturer, including emails and phone call notes, as well as copies of any receipts or return shipping labels.
The recall affects the following models: LAVH PROCEDURE (REF CDS980754T), GYN LAP HYSTERECTOMY CDS (REF CDS982662Q), DAVINCI HYSTERECTOMY CDS (REF CDS985344F), and others. The kits were distributed nationwide in the U.S.
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