Smiths Medical recalls TranStar Patient Mount Monitoring Kit 10/EA (Product Code REF MX9501T) due to potential inaccurate pressure readings 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 Patient Mount Monitoring Kits because a defect in the pressure transducer may cause inaccurate or interrupted pressure readings. This could lead to incorrect patient monitoring, which is critical for medical safety.
The defect causes leaks or failures in the pressure transducer chip, leading to inaccurate pressure monitoring. This could result in incorrect patient assessments if the device is used for critical care monitoring.
Healthcare providers using the TranStar Patient Mount Monitoring Kit for patient monitoring are most at risk, particularly those relying on accurate pressure readings for critical care.
Check for Product Code REF MX9501T with UDI/DI numbers 50351688504072 (case) or 10351688504074 (pouch). Lot numbers 4304896, 4346065, 4355385, or 4376424 are affected.
Verify the Product Code REF MX9501T and UDI/DI numbers to confirm if your kit is affected.
Due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate pressure readings or interruptions in monitoring.
Check the Product Code and UDI/DI numbers to see if your kit is affected; no specific action is required if it's not recalled.
The recall is for potential inaccurate monitoring, which could affect patient care but does not directly cause injury in normal use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0189-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0189-2025 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.
