Smiths Medical recalls TranStar Neonatal Monitoring Kit 10/EA with defective pressure transducers that may cause inaccurate readings. Affected units have specific product codes and lot numbers. Contact for replacement.
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 neonatal monitoring kits that may give incorrect pressure readings due to a leak or defect in the pressure transducer. This could lead to improper medical decisions for newborns if not fixed.
The pressure transducer in the kit may leak or have a defect in its chip, causing inaccurate pressure readings. This could lead to incorrect medical decisions for newborns if the device is not properly zeroed or monitored.
Newborns in hospitals using the TranStar Neonatal Monitoring Kit 10/EA with specific product codes and lot numbers are most at risk. Healthcare providers using these kits for neonatal care may need to take action.
Check for product code REF MX9530T and lot numbers 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, or 4366881 on the packaging or label.
Look for product code REF MX9530T and lot numbers listed above on the packaging or label.
Due to a manufacturing defect that may cause inaccurate pressure readings, interruptions in pressure monitoring, or an inability to zero the device.
Check the product code and lot numbers to see if it's affected. If it is, contact Smiths Medical for a replacement.
The product may have inaccurate readings, so it's not safe for use without a fix. Contact Smiths Medical for a replacement if you have the affected units.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0196-2025 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.
