Smiths Medical Arterial Kit recalled for pressure monitoring defect
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
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 with no reported illnesses or injuries. However, the defect affects a vital-sign monitoring device, creating risk of harm from inaccurate or interrupted pressure readings. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex Arterial Kit 1/EA (Product Code REF MX7827) worldwide. This recall affects 2,232 units.
The recall is due to a manufacturing defect in the TranStar Disposable Pressure Transducer. The defect may cause a leak or chip damage, resulting in inaccurate pressure readings, interruption of pressure monitoring, or inability to zero the device.
Affected lot numbers are: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161. For more information, refer to FDA Recall Number Z-0187-2025.
The recalled product
- Product
- medex Arterial Kit 1/EA, Product Code REF MX7827
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- inaccurate-readings
- loss-of-function
- calibration-failure
- manufacturing-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 (8)
- UDI/DI 50351688505185 (case)
- 10351688505187 (pouch)
- Lot Numbers: 4282733
- 4319605
- 4340472
- 4355338
- 4390060
- 4411161
Distribution
Distribution scope not specified by the agency.
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