Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect
Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.
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 a Class II medical device recall involving manufacturing defects that could affect critical patient monitoring functions. No illnesses or injuries have been reported in the source text, and the hazard remains theoretical at this time, placing it within the High severity category for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling medex TranStar DPT pressure transducers (Product Code REF MX950SCFT) worldwide. The recall affects units with UDI/DI 50351688503945 (case) and 10351688503947 (pouch), Lot Number 4277663.
A manufacturing defect in the disposable pressure transducer can cause inaccurate pressure monitoring, interruptions in pressure monitoring, or the inability to zero the device. The defect results from either a leak within the transducer or a defect in the transducer chip.
Healthcare providers using affected pressure transducers should be aware of the potential for monitoring failures. If inaccuracies are suspected, users should verify readings through alternative methods and contact Smiths Medical for further guidance.
The recalled product
- Product
- medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- inaccurate-pressure-monitoring
- monitoring-interruption
- device-leak
- chip-defect
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 (3)
- UDI/DI 50351688503945 (case)
- 10351688503947 (pouch)
- Lot Numbers: 4277663
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27