Z-2253-2015Class II

OxySure Model 615 disposable replacement cartridges, for portable oxygen generator

Name: Z-2253-2015 OxySure Model 615 disposable replacement cartridges, for portable oxygen generator
Creator: Oxysure Systems, Inc.
Published: 2015-06-12
License: https://open.fda.gov/license/

Oxysure Systems, Inc. / initiated 2015-06-12 / Terminated

FDA source

Oxysure Systems, Inc. began a recall of OxySure Model 615 disposable replacement cartridges, for portable oxygen generator on 2015-06-12. FDA classified it as Class II and gives the reason as "Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2253-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2015-07-24
Terminated: 2020-10-19
Recalling firm: Oxysure Systems, Inc.
Product: OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
FDA root cause: Under Investigation by firm
Action: The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.
Quantity in commerce: 1005 units
Distribution: Nationwide throughout the US and Chile, Trinidad, China
Product codes and lots: lots 61-65

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2253-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24

Product code CAW

K052396Class IIOxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. / cleared 2005-12-09

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)