Recall Z-1727-2025 ยท CAW Generator, Oxygen, Portable
Medical Depot Inc.
iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
| Date | May 9, 2025 (initiated Apr 11, 2025) |
| Status | Open, Classified |
| Reason | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT NOTICE MEDICAL DEVICE RECALL dated 4/11/25 was emailed to consignees. The recall notification instructs consignees on how to identify affected devices in their possession, destroy the affected charger cord, and provides instructions on how to obtain a replacement charger cord through Drive Devilbiss. If product was further distributed, consignees are to contact their customers; Devilbiss has a draft recall notification and recall website available for their consignees who further distributed product. For those units that are rentals, Devilbiss recommends that consignees check devic |
| Quantity | 89,532 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, ISRAEL, Italy, JAPAN, Kenya, Kuwait, Latvia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES Sunrise Medical, Oct 1, 2007 |