Smiths Medical recalls Transtar Monitoring Kit 1/EA (Product Code REF MX20103R1) due to potential inaccurate pressure readings. Affected units may have leaks or defects in the pressure transducer.
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Smiths Medical is recalling Transtar Monitoring Kits because a manufacturing defect can cause inaccurate pressure readings, interruptions in monitoring, or inability to zero the device. This could lead to incorrect medical decisions if used for patient monitoring.
The device may have leaks or defects in the pressure transducer chip, causing inaccurate pressure readings. This could lead to incorrect medical decisions if the device is used for patient monitoring.
Healthcare professionals using the Transtar Monitoring Kit for patient monitoring are most at risk. Patients relying on this device for critical pressure monitoring may be affected if the device fails.
Check for the product code REF MX20103R1 on the kit. The lot numbers are 4270117, and the UDI/DI numbers are 50351688551694 (case) and 10351688551696 (pouch).
Verify the product code REF MX20103R1 and lot numbers 4270117 to confirm if your kit is affected.
The recall is for potential inaccurate pressure readings, but it does not indicate a risk of serious injury. The hazard is low risk as the device may not cause immediate harm.
Check for the product code REF MX20103R1 and lot numbers 4270117 on the kit. The UDI/DI numbers are 50351688551694 (case) and 10351688551696 (pouch).
The recall does not specify a remedy, so you should check the product details to confirm if your kit is affected and contact Smiths Medical for further guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0185-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0185-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
