Z-1955-2018Class II

Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715...

Name: Z-1955-2018 Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715...
Creator: Dynarex Corporation
Published: 2018-05-08
License: https://open.fda.gov/license/

Dynarex Corp. / initiated 2018-05-08 / Terminated / root cause: manufacturing process

FDA source

Dynarex Corporation began a recall of 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... on 2018-05-08. FDA classified it as Class II and gives the reason as "The device is equipped with a dial that has an inaccurate flow rate indicator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1955-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-05-29
Terminated: 2018-09-18
Recalling firm: Dynarex Corp.
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.
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: The device is equipped with a dial that has an inaccurate flow rate indicator.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The Firm sent an Urgent Medical Device Recall letter on May 8, 2018. Customers were instructed : Customer/User should stop distributing/using product immediately. Customer/User is to complete the attached Medical Device Recall Return Response Acknowledgement and Receipt Form and return immediately using the fax number or email address on the form. After returning the form, please contact Dynarex Returned Goods Representative (see contact information on attached for or under (8) below) to return the product and to receive credit for the product. For further questions, please call ( 845 ) 365-8200.
Quantity in commerce: 15 devices
Distribution: US Distribution to the states of : MA and NJ
Product codes and lots: Lot number: 37979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1955-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1955-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29

Product code CAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)