iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the

FDA device recall Z-1727-2025 · posted 2025-05-09 · Open, Classified

Recall details

Recalling firm

Medical Depot Inc.

Reason for recall

Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

Action taken

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 devices as they return from rental use. Dan Hinkbein is available to assist consignees who distributed affected devices fulfill recall actions and can be contacted at dan.hinkebein@realtimeresults.net. Consignees with any issues or questions can call Drive Devilbiss Healthcare at 888-770-7017 Monday through Friday from 7:30 AM to 5:00 PM CST. Questions can also be emailed to iGo2-car-cord@realtimeresults.net. The firm has set up a website for this recall event at www.recallrtr.com/iGo2-car-cord.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CAW

Quantity affected

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, Germ

Date initiated

2025-04-11

Date posted

2025-05-09

Location

Port Washington, NY

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