medex TranStar Pressure Transducer Recall Due to Manufacturing Defect
Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
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 surgical monitoring device with a manufacturing defect that poses risk of harm during critical clinical use. No injuries or illnesses have been reported. Classified as High because it is a functional risk-of-harm product in a medical setting where device failure could lead to adverse outcomes, though no adverse events have yet been documented.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar Single OR Set (Product Code REF MX20846R2) due to a manufacturing defect affecting pressure monitoring capabilities. The defect stems from either a leak within the TranStar Disposable Pressure Transducer or a defect in the transducer chip.
The defect may cause three specific failures: inaccurate pressure readings, interruption of pressure monitoring, or inability to zero the device. In operating room settings where accurate pressure readings are critical, these malfunctions could delay detection of clinical changes during procedures.
260 units have been distributed worldwide. Affected lot numbers are 4282732 and 4287721, identified by UDI/DI 50351688508780 (case) and 10351688508782 (pouch). Healthcare facilities should identify and quarantine affected devices. Contact Smiths Medical for replacement or return instructions.
The recalled product
- Product
- medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 260
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 50351688508780 (case)
- 10351688508782 (pouch)
- Lot Numbers: 4282732
- 4287721
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.
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