OxySure Model 615 disposable replacement cartridges — Class II medical device recall Z-2253-2015
Terminated recall by Oxysure Systems, Inc., reported 2015-08-05, distributed nationwide. Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a
| Recall number | Z-2253-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oxysure Systems, Inc., Frisco, TX, United States |
| Recall initiated | 2015-06-12 |
| Classified | 2015-07-24 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2020-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CN, TT |
| Quantity | 1,005 units |
| Lot numbers | 61-65 |
| Model numbers | 615 |
Product
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2253-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.