FDA Device recall Z-2253-2015
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of OxySure Model 615 disposable replacement cartridges, for portable oxygen generator by Oxysure Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2253-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-12 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Oxysure Systems |
| Distribution | US |
Product
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
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.
Identifiers
| code_info | lots 61-65 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2253-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.