CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report

Li-Ion battery used in the Oxus Portable Oxygen recalled by Oxus America

Oxus America is recalling Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400, distributed in 17 states. The recall was initiated on 14 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codespart number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562. Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258x, 08259x, 08260x, 08649x, 08650x, 08681x, 08807x, 08808x, 08811x, 09304x, 09387x, 09388x, 09390x, 09859x, 09860x, 10089x, 10402x, 10613x, 10614x, 10616x, 05407x, 06072x, 06078x, 06080x, 06081x, 06209x, 06217x, 06226x, 06277x, 06278x, 06279x, 06299x, 06329x, 06331x, 06396x, 06432x, 06433x, 06434x, 06436x, 06442x, 06443x, 06444x, 06445x, 06446x, 06474x, 06475x, 06476x, 06481x, 06512x, 06515x, 06517x, 06518x, 06522x, 06525x, 06810x, 06872x, 06874x, 06877x, 07030x, 07112x, 07113x, 07114x, 07116x, 07154x, 07169x, 07170x, 07171x, 07173x, 07194x, 05589x, and 07749x.

Quantity recalled1724 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0768-2013
FDA event ID: 64057
Recalling firm: Oxus America, Rochester Hills, MI
Classification: Class II
Status: Terminated
Recall initiated: 14 Jan 2013
FDA classified: 2 Feb 2013
Reported: 13 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

14 Jan 2013	Recall initiated by company
2 Feb 2013	Classified by FDA	+19 days
13 Feb 2013	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

Where it was distributed

Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.

Alabama California Colorado Florida Georgia Iowa Illinois Michigan New York Ohio Oklahoma Oregon Texas Utah Virginia Wisconsin West Virginia

Questions about this recall

Is Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400 recalled?

Yes. Oxus America recalled Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400 on 14 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0768-2013.

Why was it recalled?

Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.

Which lots are affected?

part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562. Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258x, 08259x, 08260x, 08649x, 08650x, 08681x, 08807x, 08808x, 08811x, 09304x, 09387x, 09388x, 09390x, 09859x, 09860x, 10089x, 10402x, 10613x, 10614x, 10616x, 05407x, 06072x, 06078x, 06080x, 06081x, 06209x, 06217x, 06226x, 06277x, 06278x, 06279x, 06299x, 06329x, 06331x, 06396x, 06432x, 06433x, 06434x, 06436x, 06442x, 06443x, 06444x, 06445x, 06446x, 06474x, 06475x, 06476x, 06481x, 06512x, 06515x, 06517x, 06518x, 06522x, 06525x, 06810x, 06872x, 06874x, 06877x, 07030x, 07112x, 07113x, 07114x, 07116x, 07154x, 07169x, 07170x, 07171x, 07173x, 07194x, 05589x, and 07749x.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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