The Recall Desk
HighFDA (Devices)·Z-0192-2025·Announced 2024-10-30

Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction

The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of monitoring, or inability to zero the device.

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: This is an FDA Class II recall for a pressure monitoring device with manufacturing defects that could impair critical hemodynamic monitoring function. No illnesses or injuries have been reported, making this a risk-of-harm situation without confirmed patient harm.

Plain-English summary

The medex TranStar 84in (213cm) Single Monitoring Kit (Product Code REF MX9505T), manufactured by Smiths Medical ASD, Inc., is being recalled due to a manufacturing defect. Approximately 1.16 million units have been distributed worldwide.

The defect affects the disposable pressure transducer component and may result in a leak within the transducer or a defect within the transducer chip. This can cause inaccurate pressure monitoring, interruption of monitoring, or inability to zero the device.

Healthcare providers and users in possession of affected units (identified by specific lot numbers provided by the FDA) should contact Smiths Medical ASD, Inc. for guidance on device replacement or return. Affected units should not be used until replacement guidance is provided.

The recalled product

Product
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Pressure Monitoring Equipment
Hazard
Affected units
1,160,168

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 (20)

  • UDI/DI 50351688503990 (case)
  • 10351688503992 (pouch)
  • Lot Numbers: 4277670
  • 4287645
  • 4287649
  • 4299776
  • 4277696
  • 4308930
  • 4299811
  • 4308934
  • 4299812
  • 4323148
  • 4264943
  • 4264939
  • 4277694
  • 4264950
  • 4299779
  • 4308962
  • 4323175
  • 4328515

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 →

Related recalls

Same manufacturer · Smiths Medical ASD, Inc.

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Same hazard · pressure transducer defect

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