The Recall Desk

Hazard

Pressure Defect recalls

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

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2020-01-01

Of the 6 pressure 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 2 (33%) 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 pressure 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.

1–6 of 6

  • SevereFDA (Devices)·Z-0021-2020·2020-01-01

    Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect

    Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.

    Product
    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0020-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0009-2020·2019-11-13

    Teleflex Recalls Babi.Plus Pressure Relief Manifolds for Ventilators

    Teleflex is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because the devices vented gas below the stated pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0119-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Core Essentials Procedure Packs because the vitrectomy cutters do not operate within correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1213-2014·2014-03-26

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System Recalled

    Mar Cor Purification is recalling 232 Millenium HX Portable Reverse Osmosis Systems due to high inlet water pressure and solenoid valve issues that could delay dialysis treatment.

    Product
    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2012·2012-06-27

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical Inc is recalling five TX1 Tissue Removal System Consoles due to an incorrect pressure relief valve and inaccurate technical specifications.

    Product
    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confi
    Category
    Medical Device
    Distribution
    Distributed nationwide