Newport Medical HT70 and HT70- Plus Ventilators — Class I medical device recall Z-1874-2017
Terminated recall by Newport Medical Instruments Inc, reported 2017-05-10, distributed nationwide. Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus vent
| Recall number | Z-1874-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Newport Medical Instruments Inc, Costa Mesa, CA, United States |
| Recall initiated | 2017-03-30 |
| Classified | 2017-05-01 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2020-07-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HU, IE, IL, IR, IT, JO, JP, KE, KR, LB, LT, MT, MX, NL, NO, OM, PK, PL, PT, QA, RO, RS, SA, SE, SK, TN, TR, UA, ZA |
| Quantity | 12,966 |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.