Smiths Medical recalls TranStar 60in Single Monitoring Kits 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 60in Single Monitoring Kits because a manufacturing defect may cause inaccurate pressure readings or interruptions in monitoring. This could lead to incorrect medical decisions if the device is used for critical patient monitoring.
The device may show inaccurate pressure readings or stop working entirely due to a leak or defect in the pressure transducer chip. This could lead to incorrect medical decisions if the device is used for critical patient monitoring.
Healthcare providers using the TranStar 60in Single Monitoring Kit for patient monitoring are most at risk. The recall affects specific lot numbers of the product sold through medical suppliers.
Check the product code REF MX9504T and lot numbers 4277662, 4287634, or 4289405 on the case or pouch. The product was sold as a 10-pack of TranStar 60in Single Monitoring Kits.
Verify the product code REF MX9504T and lot numbers 4277662, 4287634, or 4289405 on the case or pouch.
Due to a manufacturing defect, the TranStar 60in Single Monitoring Kit may show inaccurate pressure readings or stop working entirely.
Check the product code and lot numbers to see if it's affected. If it is, contact Smiths Medical for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0191-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0191-2025 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.
