FDA Device recall Z-1561-2013
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults
- FDA Device
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults by Linde Gas North America, citing A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1561-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-08 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Linde Gas North America |
| Distribution | US |
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.
Reason
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Identifiers
| code_info | Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2013%22
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