Agency classClass IIOur severity:High FDA (Devices)·Z-0195-2025·Announced 2024-10-30

Medex TranStar Pressure Transducer Recalled Due to Manufacturing Defect

Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within 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: FDA Class II recall of a critical pressure-monitoring medical device with significant potential for patient harm due to inaccurate or interrupted monitoring. However, no injuries or illnesses have been reported, placing this in the high-risk category where the potential for harm is clear but actual harm has not yet occurred.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 1110 units of the medex TranStar DPT (Disposable Pressure Transducer) with Two Stopcocks, Product Code REF MX950X2SC, due to a manufacturing defect.

The defect may cause users to experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. The defect results from either a leak within the transducer or a defect in the transducer chip.

The affected product is distributed worldwide. Lot numbers 4363257 and 4385760 are included in this recall. Healthcare facilities and medical professionals using this device should discontinue use and contact Smiths Medical ASD, Inc. for instructions on returning or replacing affected units.

The FDA classified this as a Class II recall. No injuries or illnesses have been reported to date.

The recalled product

Product: medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Pressure Monitoring
Hazard: inaccurate-pressure-monitoring
device-malfunction
manufacturing-defect
Affected units: 1,110

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 (4)

UDI/DI 50351688503921 (case)
10351688503923 (pouch)
Lot Numbers: 4363257
4385760

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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