Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable 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 without reported hospitalizations, injuries, or deaths. However, the manufacturing defect creates a clear risk of harm to patients relying on accurate pressure monitoring, qualifying as a risk-of-harm product per the rubric criterion for Score 3.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 1,000 units of the medex TranStar DPT (Disposable Pressure Transducer) with Stopcock & 30cc Flush, Product Code REF MX950SCNT, due to a manufacturing defect.
The defect may cause inaccurate pressure monitoring, interruption in pressure monitoring, or inability to zero the device. These issues can result from a leak within the transducer or a defect within the transducer chip.
The recalled product has been distributed worldwide. Affected lot numbers are 4293126, 4309186, 4316649, 4323123, 4328467, and 4346049.
The recalled product
- Product
- medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 1,000
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 (8)
- UDI/DI 50351688503938 (case)
- 10351688503930 (pouch)
- Lot Numbers: 4293126
- 4309186
- 4316649
- 4323123
- 4328467
- 4346049
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.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · pressure monitoring failure
See all →- HighMedex TranStar Kids blood sample kit recalled for pressure monitoring failures
FDA (Devices) · 2024-10-30
- HighMedex TranStar Kids Blood Sample Kit Pressure Monitoring Defect Recall
FDA (Devices) · 2024-10-30
- Highmedex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect
FDA (Devices) · 2024-10-30
Similar recalls
- HighSmiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk
FDA (Devices) · 2018-12-05
- SevereSmiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects
FDA (Devices) · 2021-04-28
- HighSmiths Medical blood sampling system recalled for pressure reading errors
FDA (Devices) · 2021-10-20
- HighMedex 700PSI Stopcock with Rotator Recalled Due to Seal Defect
FDA (Devices) · 2024-01-24
- HighICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
FDA (Devices) · 2016-11-23
- HighSmiths Medical Recalls Medex High Pressure Tubing Due to Weld Defects
FDA (Devices) · 2021-04-28