Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OxySure Model 615 disposable replacement cartridges Recalled by Oxysure Systems, Inc. Due to Flow rate of the recalled replacement cartridges does...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Oxysure Systems, Inc. directly.
Affected Products
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Quantity: 1005 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Oxysure Systems, Inc.
Oxysure Systems, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report