CLASS II Device recall · Reported 26 Jun 2013 · FDA Enforcement Report
Medicycl-e- Lite Portable Oxygen System An integrated recalled
Linde Gas North America is recalling Medicycl-e- Lite Portable Oxygen System An integrated portable oxygen delivery system, distributed nationwide in the US. The recall was initiated on 8 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1561-2013
- FDA event ID
- 64856
- Recalling firm
- Linde Gas North America, New Providence, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2013
- FDA classified
- 20 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Mar 2013 | Recall initiated by company | |
| 20 Jun 2013 | Classified by FDA | +104 days |
| 26 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution.
Questions about this recall
Why was it recalled?
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Which lots are affected?
Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Where was it sold?
Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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