Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 10, 2017
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restrict
Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operati…
Newport Medical Instruments Inc recalled Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport H… - a critical-severity action.
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport H… was recalled by Newport Medical Instruments Inc in May 10, 2017. Reason: Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ven…. Check the official notice for the remedy. Verify recall #Z-1874-2017 with the FDA Devices before acting.
The recall
Newport Medical Instruments Inc issued this critical-severity FDA Devices recall-Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ven….
- Critical
- severity level
- 13K units
- affected scope
- Class I
- classification
- May 10, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1874-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1874-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on March 30, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Newport Medical Instruments Inc is listed as the recalling firm, operating out of Costa Mesa, CA. Federal records list the affected scope as 12,966.
The documented reason for this recall is: Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,966
Related Recalls
6
3 from same agency
Product description
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Reason for recall
Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1874-2017 |
| Date reported | May 10, 2017 |
| Date initiated | March 30, 2017 |
| Recalling firm | Newport Medical Instruments Inc |
| Firm location | Costa Mesa, CA |
| Affected scope | 12,966 |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1874-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.. Recalled by Newport Medical Instruments Inc. Units affected: 12,966.
Why was this product recalled? ▼
Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Critical. Recall number: Z-1874-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, Qatar, Romania, Russian Federation South Africa, Spain, Turkey, United Arab Emirates, United Kingdom Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana Bulgaria, Cyprus, Czech Republic, Denmark, Egypt, Finland, France Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon Lithuania, Macedonia, Malawi, Malta, Mauritius, Mozambique, Netherlands Norway, Oman, Poland, Portugal, Qatar, Republic of Moldova, Romania Saudi Arabia, Serbia, Slovakia, Sudan, Sweden, Switzerland, Tunisia Turkey, Uganda, Ukraine, United Kingdom, Yemen, and Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1874-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 10, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.