The Recall Desk

Hazard

Missing Contraindications recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-07-06

Of the 4 missing contraindications 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 missing contraindications 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.

1–4 of 4

  • ModerateFDA (Devices)·Z-1302-2022·2022-07-06

    Digital IVUS Catheter Recalled for Missing Contraindication Information

    Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2022·2022-07-06

    IVUS Catheter Recall: Missing Contraindications in Instructions

    Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2016·2016-02-10

    Bard Denali Intravascular Filters Recalled for Missing Contraindications

    Bard Peripheral Vascular Inc is recalling 1,183 Denali intravascular filters because the instructions for use are missing critical contraindications regarding sepsis and nickel-titanium allergies.

    Product
    Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
    Category
    Medical Device
    Distribution
    1 state