Z-2250-2012Class I

Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus

Name: Z-2250-2012 Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus
Creator: Newport Medical Instruments Inc
Published: 2012-08-03
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2012-08-03 / Terminated / root cause: manufacturing process

FDA source

Newport Medical Instruments Inc began a recall of Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or... on 2012-08-03. FDA classified it as Class I and gives the reason as "May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2250-2012
Classification: Class I
Status: Terminated
Initiated: 2012-08-03
Posted: 2014-04-14
Terminated: 2014-04-14
Recalling firm: Newport Medical Instruments, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Newport Medical sent an Urgent Field Correction Notice letter dated August 3, 2012 to all affected customers, via DHL and FedEx courier services. The letter identified the affected product, reason for recall and actions to be taken. Customers were instructed to immediately stop using the affected ventilator and retrieve the replacement kit provided free of charge. In addition, the letter states that if the product was further distributed, to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Replacement form as replacements are completed. For questions contact Newport Medical Technical Support Department at 800-451-3111, extension 282, for U.S. customers; 714-427-5811, extension 500, for international customers.".
Quantity in commerce: 72
Distribution: Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Product codes and lots: Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)