Z-0272-2016Class II

Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter...

Name: Z-0272-2016 Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter...
Creator: Precision Medical, Inc.
Published: 2015-10-08
License: https://open.fda.gov/license/

Precision Medical, Inc. / initiated 2015-10-08 / Terminated / root cause: labeling and UDI

FDA source

Precision Medical, Inc. began a recall of Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute on 2015-10-08. FDA classified it as Class II and gives the reason as "These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0272-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-08
Posted: 2015-11-13
Terminated: 2016-10-27
Recalling firm: Precision Medical, Inc.
Product: Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm sent "Attention Field Corrective Action" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly.
Quantity in commerce: 315
Distribution: Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.
Product codes and lots: Lot numbers 072215 and 072315.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0272-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0272-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-13

Product code CAN

K901831Class IPrecision Medical Oxygen RegulatorPrecision Medical, Inc. / cleared 1990-08-14

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)