The Recall Desk

Hazard

Barotrauma recalls

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

What the numbers show

Total
10
Critical
0
Severe
4
Most recent
2026-04-08

Of the 10 barotrauma recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (40%) 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 barotrauma 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.

1–10 of 10

  • SevereFDA (Devices)·Z-1637-2026·2026-04-08

    Volara ventilator adapter recalled as Class I over desaturation and barotrauma

    Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.

    Product
    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0638-2024·2024-01-10

    Philips Trilogy Evo respiratory devices recalled for missing contraindication statement

    Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.

    Product
    Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2022·2022-06-08

    In-Line Ventilator Adaptor Recall: Risk of Reduced Oxygenation or Barotrauma

    Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.

    Product
    In-Line ventilator adaptor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0677-2016·2016-01-27

    GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.

    Product
    GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0680-2016·2016-01-27

    GE Aisys Anesthesia System Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling 13 Aisys Anesthesia Systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially resulting in barotrauma.

    Product
    GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2016·2016-01-27

    GE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect

    GE Medical Systems is recalling 240 anesthesia device service kits because a drive gas check valve could become stuck open, potentially causing excessive pressure in the patient breathing circuit.

    Product
    Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2016·2016-01-27

    GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.

    Product
    GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2016·2016-01-27

    GE Healthcare Aestiva MRI Ventilator Recalled for Valve Defect

    GE Medical Systems is recalling 84 Aestiva MRI anesthesia systems because a drive gas check valve may become stuck open, potentially causing excessive pressure in the patient breathing circuit.

    Product
    GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2016·2016-01-27

    GE Healthcare Aestiva 7900 Ventilator Recall for Stuck Valve Risk

    GE Medical Systems is recalling two Aestiva 7900 ventilators because a stuck valve could cause excessive pressure and barotrauma.

    Product
    GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during su
    Category
    Medical Device
    Distribution
    Distributed nationwide