The Recall Desk

Hazard

Monitoring Defect recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2024-10-30

Of the 5 monitoring defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all monitoring defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • HighFDA (Devices)·Z-0183-2025·2024-10-30

    Medex TranStar ICP Pressure Monitoring Device Recalled Due to Manufacturing Defect

    Smiths Medical is recalling the medex TranStar Single ICP Set because a manufacturing defect may cause inaccurate pressure monitoring, monitoring interruptions, or inability to zero the device.

    Product
    medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2320-2021·2021-08-25

    RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response

    Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.

    Product
    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2014·2014-03-12

    GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure

    GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.

    Product
    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervis
    Category
    Medical Device
    Distribution
    Distributed nationwide