Linde Gas North America Llc: Medical Device Recall in 2013 - (Recall #: Z-1561-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 8, 2013

Date Posted: June 26, 2013

Recall Number: Z-1561-2013

Event ID: 64856

Reason for Recall:

A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.

Status: Terminated

Product Quantity: 52,264 units (1106 units)

Code Information:

Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03

Distribution Pattern:

Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated