Class I recallOngoing

Newport HT70 Ventilator recall — FDA event 96774

FDA · FDA event 96774 · Posted Jun 9, 2025

Published Jun 9, 2025Updated Aug 16, 2026Source last checked: 2026-08-16 22:21:39 UTC

What happened

Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 05/21/2025 recall notices were mailed and/or emailed customers who were asked to do the following:
Healthcare providers with patients currently ventilated with affected ventilators should assess overall risk and appropriate timing for device replacement.
- A patient connected to a ventilator requires the constant attention of trained caregivers to the patient's condition. - Always have an alternate power source and means of ventilation available when the ventilator is in use. - Always use appropriate monitors to ensure sufficient oxygenation and ventilation when the ventilator is in use. - If, at any time, the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact the patient's health care provider/physician immediately. - Follow Patient Set-up Procedure described in Operator's Manuals to verify the shutdown alert alarm's functionality prior to use.
Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification.
-If affected ventilator or service part is currently in use, remove and replace it with an alternate means of ventilation. After completing the transition, quarantine all affected ventilators and service parts and follow your facility's processes for removal and disposal. Patients are asked to return affected devices to their healthcare provider.
Complete/return the Acknowledgement Form via email to rs.gmbmitgfca@medtronic.com. Questions or concerns contact firm's Technical Service at 1-800-255-6774 Distribute notice to all relevant personnel within your organization and any organizations where ventilators or service parts may have been transferred or distributed. Provide the enclosed patient letter to any of your patients using this ventilator in the home care setting to inform them of this recall.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Newport HT70 Ventilator by Covidien.

Products affected by FDA event 96774
Model	Description	Lot / serial range	Manufactured	Status
Z-1915-2025	Z-1915-2025	REF/UDI-DI/Serial Numbers: HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159, N10HT700710161, N10HT700710162, N10HT700710163, N10HT700710164, N10HT700810194, N10HT700810199, N10HT700810202, N10HT700810204, N10HT700810205, N10HT700810206, N10HT700910223, N10HT700910227, N10HT701010279, N10HT701011015, N10HT701011016, N10HT701111044, N10HT701111048, N10HT701111049, N10HT701111050, N11HT700111137, N11HT700111139, N11HT700111141, N11HT700111142, N11HT700111143, N11HT700111144, N11HT700211145, N11HT700211155, N11HT700211160, N11HT700211161, N11HT700211163, N11HT700211164, N11HT700311168, N11HT700311169, N11HT700311170, N11HT700311183, N11HT700311184, N11HT700311185, N11HT700311186, N11HT700311188, N11HT700311189, N11HT700311191, N11HT700311192, N11HT700311193, N11HT700311195, N11HT700311196, N11HT700311197, N11HT700311201, N11HT700311202, N11HT700311203, N11HT700311204, N11HT700311207, N11HT700311208, N11HT700311209, N11HT700311233, N11HT700311234, N	Not provided in the normalized record	Ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Czechia, Israel, Norway, Russian Federation, United Kingdom, Canary Islands, Kenya, Czech Republic, Croatia , Estonia, Maldova, Palestine.
Units affected: See official FDA record
Category: Ventilators

Timeline

May 21, 2025
Recall initiated
Date recorded by the FDA.
Jun 9, 2025
Posted by FDA
The recall event appeared in the FDA source.
Aug 16, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96774
Published: Jun 9, 2025
Source checked: 2026-08-16 22:21:39 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Loading MedWatcher information…

Newport HT70 Ventilator recall — FDA event 96774

FDA · FDA event 96774 · Posted Jun 9, 2025

Published Jun 9, 2025Updated Aug 16, 2026Source last checked: 2026-08-16 22:21:39 UTC

What happened

Affected products and models

This FDA record lists Newport HT70 Ventilator by Covidien.

Products affected by FDA event 96774
Model	Description	Lot / serial range	Manufactured	Status
Z-1915-2025	Z-1915-2025	REF/UDI-DI/Serial Numbers: HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159, N10HT700710161, N10HT700710162, N10HT700710163, N10HT700710164, N10HT700810194, N10HT700810199, N10HT700810202, N10HT700810204, N10HT700810205, N10HT700810206, N10HT700910223, N10HT700910227, N10HT701010279, N10HT701011015, N10HT701011016, N10HT701111044, N10HT701111048, N10HT701111049, N10HT701111050, N11HT700111137, N11HT700111139, N11HT700111141, N11HT700111142, N11HT700111143, N11HT700111144, N11HT700211145, N11HT700211155, N11HT700211160, N11HT700211161, N11HT700211163, N11HT700211164, N11HT700311168, N11HT700311169, N11HT700311170, N11HT700311183, N11HT700311184, N11HT700311185, N11HT700311186, N11HT700311188, N11HT700311189, N11HT700311191, N11HT700311192, N11HT700311193, N11HT700311195, N11HT700311196, N11HT700311197, N11HT700311201, N11HT700311202, N11HT700311203, N11HT700311204, N11HT700311207, N11HT700311208, N11HT700311209, N11HT700311233, N11HT700311234, N	Not provided in the normalized record	Ongoing

Distribution

Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Czechia, Israel, Norway, Russian Federation, United Kingdom, Canary Islands, Kenya, Czech Republic, Croatia , Estonia, Maldova, Palestine.

Units affected

See official FDA record

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

Newport HT70 Ventilator recall — FDA event 96774

Follow Newport HT70 Ventilator

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Newport HT70 Ventilator recall — FDA event 96774

Follow Newport HT70 Ventilator

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline