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Open, Classified

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

FDA Recall Z-0182-2025 · Posted 2024-10-23

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeGWM
Date Initiated2024-09-24
Product Quantity260 units

Reason for Recall

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Firm Action

Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020780TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICPMedex, Inc. · 2002-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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