Medex TranStar pressure monitoring sets recalled due to manufacturing defect
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a critical medical device where the manufacturing defect poses a patient safety risk by causing inaccurate or interrupted pressure monitoring. No illnesses or injuries have been reported, placing this in the risk-of-harm with no reported injury category.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 1,640 units of medex TranStar MONITORING SET W/SAMPLING PORT (Product Code REF MXG300260) due to a manufacturing defect. The affected product is distributed worldwide.
A manufacturing defect in the pressure transducer component can result in inaccurate pressure monitoring, interruption of pressure monitoring, or inability to properly zero the device. The defect stems from either a leak within the TranStar Disposable Pressure Transducer or a defect within the transducer chip.
Affected lot numbers include: 4270120, 4297963, 4316640, 4319604, 4323118, 4287727, 4359814, 4387976, and 4340473. For additional information, refer to FDA Recall Number Z-0204-2025.
The recalled product
- Product
- medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 1,640
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 (11)
- UDI/DI 50351688518833 (case)
- 10351688518835 (pouch)
- Lot Numbers: 4270120
- 4297963
- 4316640
- 4319604
- 4323118
- 4287727
- 4359814
- 4387976
- 4340473
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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