Newport HT70 and HT70 Plus Ventilators — Class I medical device recall Z-2250-2012
Terminated recall by Newport Medical Instruments Inc, reported 2012-09-12, distributed nationwide. May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure
| Recall number | Z-2250-2012 |
|---|---|
| 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 | 2012-08-03 |
| Classified | 2012-08-31 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2014-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CL, EG, FR, HK, IN, JP, NO, PH, ZA |
| Quantity | 72 |
| Serial numbers | N12HT700514226, N12HT700514231, N12HT700514233, N12HT700514236, N12HT700514238, N12HT700614280, N12HT700614282, N12HT700614299, N12HT700614301, N12HT700614309, N12HT720410266, N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294, N12HT720510300, N12HT720510302, N12HT720510322, N12HT720510330 and 2 more |
| Model numbers | HT70 |
Product
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system 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 HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The 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
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2250-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.