System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140 System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry
Brand
System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140
Lot Codes / Batch Numbers
All units are under recall.
Products Sold
All units are under recall.
System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140 is recalling System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transpo due to System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'
Recommended Action
Per FDA guidance
Distributors were contacted by telephone with follow up letter sent via registered mail on 5/1/2002. System O2 has volunteered to handle mailings to end users and sub-distributors, and is also establishing a URL to warehouse recall information and forms. All Distributors, sub distributors, retailers and end users will be logged in a data base as Master Distributors forward that information. Results and effectiveness data will be logged in data base for tracking purposes.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IN
Page updated: Jan 10, 2026