FDA Medical Device Recalls (openFDA)
Linde Gas North America Llc: 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.
- Recall number
- Z-1561-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-03-08
- Posted
- 2013-06-20
- Terminated
- 2015-02-03
- Reason
- A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
- 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
- 52,264 units (1106 units)
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAN
- Firm FEI
- 3007529772
- Firm city
- New Providence
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28