Recall archive / FDA company announcement
Newport™: Newport™ HT70 and HT70 Plus ventilators and certain related service parts — FDA announcement Jun 11, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jun 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Newport™ HT70 and HT70 Plus ventilators and certain related service parts
- Reason
- Device & Drug Safety - Potential Defect
- Classification
- Not supplied
- Recalling firm
- Medtronic
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- ebed8e9711a4be0b
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The following table identifies the item name, manufacture date and use by date:; If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 medical device reports (MDRs) associated with this issue, including two serious injuries and one death. HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risks of injury or death due to unanticipated ventilator failures. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Jun 11, 2025
- Company announcement date
- Jun 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.