MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen… — Class II medical device recall Z-1561-2013
Terminated recall by Linde Gas North America Llc, reported 2013-06-26, distributed nationwide. A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
| Recall number | Z-1561-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linde Gas North America Llc, New Providence, NJ, United States |
| Recall initiated | 2013-03-08 |
| Classified | 2013-06-20 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2015-02-03 |
| Distributed | Nationwide (US) |
| Lot numbers | 20/03, 25/07, 48/06 |
| Model numbers | M70500037 |
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 for recall
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1561-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.