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 Medline medical procedure convenience kits are designed for use in urology procedures, providing essential tools and devices for healthcare providers. These kits are critical in ensuring efficient and safe medical interventions.
The design flaw allows saline solution to leak into areas of the device not intended for fluid exposure. This can lead to hazardous situations during medical procedures, including potential electrical risks.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face immediate safety risks while using these kits, which may compromise the quality of care during urological procedures.
Serial numbers and lot numbers can typically be found on the product's outer packaging or labeling.
Anticipate a refund processing timeline of 4-6 weeks after submitting your request to Medline.
Keep copies of receipts, correspondence with the manufacturer, and photographs of the product for your records.
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.
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