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Medex MX9545Recalls & reported problems

Icu Medical, Inc. · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

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. How this data works · Data updated Oct 13, 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-0199-2025 · Root cause: Process control · 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

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.