Reviewed V1 category

Ventilators

Devices that support or control breathing in home, transport, and clinical settings.

FDA product codes and descriptions are normalized into this consumer-facing category. Raw regulator terminology remains source evidence rather than separate public category pages.

0 tracked devices · 17 recall records

Devices in this category

No tracked devices yet

MedWatcher has not added devices in this category yet. Recall records referencing the category will still appear below.

Recent recall records

Class I recallOngoing

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of…

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below…

FDA · FDA event 98554Posted May 1, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98540

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

FDA · FDA event 98540Posted Apr 2, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98537

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA · FDA event 98537Posted Mar 26, 2026

Class I recallOngoing

Hamilton C6 recall — FDA event 97079

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an…

FDA · FDA event 97079Posted Aug 19, 2025

Class I recallOngoing

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Potential for the manometer port being blocked rendering the manometer non-functional.

FDA · FDA event 97166Posted Aug 13, 2025

Class I recallOngoing

DreamStation Auto recall — FDA event 97191

Devices may possess a programming error resulting in an incorrect device configuration.

FDA · FDA event 97191Posted Aug 8, 2025

Manufacturers in this category

Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.

Related guides

No guides reference this category yet. Browse all guides.

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Reviewed V1 category

Ventilators

Devices that support or control breathing in home, transport, and clinical settings.

FDA product codes and descriptions are normalized into this consumer-facing category. Raw regulator terminology remains source evidence rather than separate public category pages.

0 tracked devices · 17 recall records

Devices in this category

No tracked devices yet

MedWatcher has not added devices in this category yet. Recall records referencing the category will still appear below.

Recent recall records

Class I recallOngoing

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98540

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

FDA · FDA event 98540Posted Apr 2, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98537

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA · FDA event 98537Posted Mar 26, 2026

Class I recallOngoing

Hamilton C6 recall — FDA event 97079

FDA · FDA event 97079Posted Aug 19, 2025

Class I recallOngoing

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Potential for the manometer port being blocked rendering the manometer non-functional.

FDA · FDA event 97166Posted Aug 13, 2025

Class I recallOngoing

DreamStation Auto recall — FDA event 97191

Devices may possess a programming error resulting in an incorrect device configuration.

FDA · FDA event 97191Posted Aug 8, 2025

Manufacturers in this category

Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.

Related guides

No guides reference this category yet. Browse all guides.

Ventilators

Follow Ventilators

Devices in this category

Recent recall records

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

VOCSN+Pro package recall — FDA event 98888

VOCSN V+Pro package recall — FDA event 98554

Philips Respironics Trilogy Evo recall — FDA event 98540

Philips Respironics Trilogy Evo recall — FDA event 98537

Hamilton C6 recall — FDA event 97079

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

DreamStation Auto recall — FDA event 97191

Manufacturers in this category

Related guides

Ventilators

Follow Ventilators

Devices in this category

Recent recall records

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

VOCSN+Pro package recall — FDA event 98888

VOCSN V+Pro package recall — FDA event 98554

Philips Respironics Trilogy Evo recall — FDA event 98540

Philips Respironics Trilogy Evo recall — FDA event 98537

Hamilton C6 recall — FDA event 97079

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

DreamStation Auto recall — FDA event 97191

Manufacturers in this category

Related guides