Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects
Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may lead to inaccurate monitoring or inability to zero the device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 1,100 units of the medex TranStar Disposable Transducer (Product Code REF MX950). The recall is due to a manufacturing defect that may result in a leak within the transducer or a defect within the transducer chip.
These defects may cause users to experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. The affected products were distributed worldwide.
Users should stop using the affected devices and contact Smiths Medical ASD, Inc. for further instructions. The recall number is Z-0188-2025.
The recalled product
- Product
- medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 1,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI/DI 50351688504126 (case)
- 10351688504128 (pouch)
- Lot Numbers: 4293125
- 4328466
- 4277644
- 4349995
- 4363255
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 24 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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