Z-1561-2013Class II

MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide...

Name: Z-1561-2013 MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide...
Creator: Linde Gas North America Llc
Published: 2013-03-08
License: https://open.fda.gov/license/

Linde Gas North America, LLC / initiated 2013-03-08 / Terminated / root cause: manufacturing process

FDA source

Linde Gas North America Llc began a recall of MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI... on 2013-03-08. FDA classified it as Class II and gives the reason as "A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs". 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-1561-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2013-06-20
Terminated: 2015-02-03
Recalling firm: Linde Gas North America, LLC
Product: MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance. If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action. Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427).
Quantity in commerce: 52,264 units (1106 units)
Distribution: Nationwide distribution.
Product codes and lots: Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1561-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1561-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-20

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)