CAREstream ProNox Nitrous Oxide Delivery System labeled as the… — Class II medical device recall Z-2887-2018
Terminated recall by CAREstream Medical LLC, reported 2018-08-29, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of
| Recall number | Z-2887-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CAREstream Medical LLC, Altamonte Springs, FL, United States |
| Recall initiated | 2018-05-15 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2025-12-17 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | CA, MA |
| Quantity | 919 units |
| Model numbers | CMI-0100-PNX-XXX |
Product
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
Reason for recall
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
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-2887-2018. 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.