FDA Medical Device Recalls (openFDA)
Oxus America, Inc.: 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.
- Recall number
- Z-0768-2013
- Recalling firm
- Oxus America, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-01-14
- Posted
- 2013-02-02
- Terminated
- 2013-07-17
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Oxus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-475-1568 for information related to this recall.
- Quantity
- 1724 total units
- Distribution
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K020324"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3008841036
- Firm city
- Rochester Hills
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28