Dynarex CGA870 All Brass Oxygen Regulator — Class II medical device recall Z-1955-2018
Terminated recall by Dynarex Corporation, reported 2018-06-06, distributed in MA, NJ. The device is equipped with a dial that has an inaccurate flow rate indicator.
| Recall number | Z-1955-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynarex Corporation, Orangeburg, NY, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-05-29 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2018-09-18 |
| Distributed | MA, NJ |
| Quantity | 15 devices |
| UPC / GTIN / UDI-DI | 00616784522715 |
| Lot numbers | 37979 |
| Model numbers | 5227A |
Product
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
Reason for recall
The device is equipped with a dial that has an inaccurate flow rate indicator.
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-1955-2018. 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.