FDA Medical Device Recalls (openFDA)
Oxysure Systems, Inc.: OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Recall number
- Z-2253-2015
- Recalling firm
- Oxysure Systems, Inc.
- Product
- OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Status
- Terminated
- Initiated
- 2015-06-12
- Posted
- 2015-07-24
- Terminated
- 2020-10-19
- Reason
- 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.
- 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
- 1005 units
- Distribution
- Nationwide throughout the US and Chile, Trinidad, China
- Lot, serial or model codes
- lots 61-65
- 510(k) numbers
- ["K052396"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3004167951
- Firm city
- Frisco
- Firm state
- TX
- 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