The Recall Desk

Hazard

Respiratory Hazard recalls

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

What the numbers show

Total
12
Critical
0
Severe
6
Most recent
2025-03-26

Of the 12 respiratory hazard recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (50%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all respiratory hazard 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.

1–12 of 12

  • HighFDA (Devices)·Z-1384-2025·2025-03-26

    Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk

    Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2025·2025-01-01

    Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.

    Product
    FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Module Failure Risk

    BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.

    Product
    FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.

    Product
    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2025·2024-10-30

    Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection

    Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.

    Product
    Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3208-2024·2024-10-09

    Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency

    Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.

    Product
    Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2024·2024-09-11

    Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk

    Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.

    Product
    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2024·2023-11-29

    RescuMed Manual Resuscitators Recalled for CO2 Rebreathing Risk

    SunMed Holdings recalls RescuMed manual resuscitators due to a backwards leak in the manometer allowing CO2 rebreathing. Affected models distributed nationwide across 32 US states.

    Product
    Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1877-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Risk, FDA Class I Recall

    Teleflex LLC is recalling approximately 15,810 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The affected units were distributed nationwide, including Puerto Rico.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2018·2018-01-31

    Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk

    Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow into patient airways.

    Product
    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·09036·2008-11-04

    Krylon UV Fabric Protector Recalled for Respiratory Hazard

    Sherwin-Williams is recalling Krylon UV Fabric Protector because fumes can cause serious respiratory issues. One consumer was hospitalized for difficulty breathing.

    Product
    Krylon "Outdoor Spaces" UV Fabric Protector
    Category
    Consumer Product
    Distribution
    Distributed nationwide