Smiths Medical recalls TranStar Single OR Set 1/EA due to potential inaccurate pressure monitoring from a manufacturing defect 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 Single OR Set 1/EA medical devices because a manufacturing defect may cause inaccurate pressure readings or inability to zero the device. This could lead to improper medical treatment if used in critical care settings.
The device may show incorrect pressure readings or fail to zero properly due to a leak or defect in the pressure trans:ducer chip. This could lead to improper medical decisions if used for critical care monitoring.
Healthcare professionals using the TranStar Single OR Set for blood pressure monitoring in critical care settings are most at risk. Patients receiving this device could experience treatment errors if pressure readings are inaccurate.
Check for product code REF MX20846R2 with lot numbers 4282732 or 4287721. The device comes in a case labeled 50351688508780 and a pouch labeled 10351688508782.
Verify the product code REF MX20846R2 and lot numbers 4282732 or 4287721 on the case and pouch labels.
The recall states the device may have inaccurate pressure monitoring due to a manufacturing defect, but it does not specify that the device is unsafe if used correctly.
The recall record does not provide a remedy, so no specific action is required beyond checking if you have the affected product.
Look for product code REF MX20846R2 with lot numbers 4282732 or 4287721 on the case (50351688508780) and pouch (10351688508782).
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0182-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0182-2025 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.
