Medex MX9548Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K070340, K942377); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 24, 2024Open, Classified

   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.

   Z-0201-2025 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070340, K942377. One submission often covers many models, so check the product and lot details in each record.

• Z-0184-2025 · Sep 24, 2024 · Open, Classified
  medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
• Z-0186-2025 · Sep 24, 2024 · Open, Classified
  medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
• Z-0185-2025 · Sep 24, 2024 · Open, Classified
  medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1