Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: Recalled by CAREstream Medical LLC Due to Two analgesic gas delivery system oxygen/nitrous oxide mixers...
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 CAREstream Medical LLC directly.
Affected Products
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
Quantity: 919 Units Total
Why Was This Recalled?
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Where Was This Sold?
This product was distributed to 47 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About CAREstream Medical LLC
CAREstream Medical LLC 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