The Recall Desk

Hazard

Setup Difficulty recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-12-06

Of the 2 setup difficulty 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 setup difficulty 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.

1–2 of 2

  • ModerateFDA (Devices)·Z-0412-2024·2023-12-06

    FloTrac Pressure Monitoring Sensor Recalled for Setup Flushing Difficulties

    Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.

    Product
    FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0413-2024·2023-12-06

    TruWave Pressure Monitoring Set Recalled for Potential Flushing Difficulties

    Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.

    Product
    TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm
    Category
    Medical Device
    Distribution
    51 states