The Recall Desk

Hazard

Ventilator recalls

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

What the numbers show

Total
7
Critical
2
Severe
5
Most recent
2025-08-27

Of the 7 ventilator recalls we have scored against our rubric, 2 (29%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (71%) 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 ventilator 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.

1–7 of 7

  • CriticalFDA (Devices)·Z-2328-2025·2025-08-27

    Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation

    Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.

    Product
    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2167-2025·2025-08-06

    Hamilton coaxial breathing circuits may have a crack in blue tubing

    Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.

    Product
    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2037-2025·2025-07-09

    BiPAP A40 ventilators are not indicated for respiratory failure patients

    The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.

    Product
    BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2025·2025-07-09

    BiPAP V30 Auto ventilators are not indicated for respiratory failure

    The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.

    Product
    BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2014-2025·2025-07-09

    Servo-n ventilators may measure patient circuit compliance inaccurately

    The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.

    Product
    Servo-n Ventilator System. Model Number: 6694800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2013-2025·2025-07-09

    Servo-u ventilators may measure patient circuit compliance inaccurately

    The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.

    Product
    Servo-u Ventilator System. Model Number: 6688600.
    Category
    Medical Device
    Distribution
    Distributed nationwide