Agency classClass IIOur severity:High FDA (Devices)·Z-0202-2025·Announced 2024-10-30

medex TranStar Pressure Transducer Stopcock Recalled for Manufacturing Defect

Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.

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: This is an FDA Class II recall of a medical monitoring device with a manufacturing defect that could compromise patient safety through inaccurate or interrupted pressure monitoring. However, no illnesses or injuries have been reported, placing it in the 'High' category as a risk-of-harm product without actualized harm.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 380 units of the medex TranStar Stopcock w/Ext. (Product Code REF MXG300242) due to a manufacturing defect. This device is distributed worldwide.

The defect is located in the TranStar Disposable Pressure Transducer and can occur either as a leak within the transducer or as a chip defect. As a result, users may experience inaccurate pressure monitoring, interruption of pressure monitoring, or an inability to zero the device.

The recall affects units with lot numbers 4346040, 4385749, 4400278, and 4440647, identified by their UDI/DI codes. Healthcare facilities and individual users should verify whether they have affected units using the lot numbers provided.

If your facility has units matching the recalled lot numbers, discontinue use and contact Smiths Medical ASD, Inc. or the FDA for guidance on corrective actions.

The recalled product

Product: medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Pressure Transducer
Hazard: inaccurate-monitoring
monitoring-interruption
calibration-failure
transducer-defect
Affected units: 380

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 (6)

UDI/DI 50351688517782 (case)
10351688517784 (pouch)
Lot Numbers: 4346040
4385749
4400278
4440647

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.

See all 24 products in this recall →

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