Smiths Medical recalls TranStar Single ICP Set 1/EA with product code REF MX20897 due to potential inaccurate pressure monitoring. Affected units may have leaks or defective transducer chips causing interruptions in pressure readings.
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 Single ICP Set 1:1 units that may show inaccurate pressure readings or stop working properly. This could lead to incorrect medical decisions if used in critical care settings.
The device may have leaks or defective transducer chips that cause inaccurate pressure readings, interruptions in monitoring, or inability to zero the device. This could lead to incorrect medical decisions if used in critical care.
Healthcare professionals using the TranStar Single ICP Set for intracranial pressure monitoring are most at risk. Patients in critical care settings relying on this device for accurate pressure readings may be affected.
Check for product code REF MX20897, lot numbers 4323116, or UDI/DI numbers 50351688508551 (case) and 10351688508553 (pouch).
Verify product code REF MX20897, lot numbers 4323116, or UDI/DI numbers 50351688508551 (case) and 10351688508553 (pouch).
Due to a manufacturing defect that may cause inaccurate pressure monitoring, interruptions in pressure monitoring, or inability to zero the device.
The recall record does not specify a remedy, so check with Smiths Medical for further instructions.
The recall indicates potential for inaccurate pressure readings, but does not specify a risk of serious injury.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0183-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0183-2025 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.
