FDA Recall Open, Classified

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.

Recall: Z-1727-2025 · Initiated April 11, 2025

Recall

Recall Number
Z-1727-2025
Event Number
96700
Firm
Medical Depot Inc.
FEI Number
3002997602
Product Code
CAW
Status
Open, Classified
Root Cause
Nonconforming Material/Component
Initiated
April 11, 2025
Posted
May 9, 2025
Address
99 Seaview Blvd, Fl 2, Port Washington, NY, 11050-4606

Description

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.

Reason

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

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 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 [email protected]. 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 [email protected]. The firm has set up a website for this recall event at www.recallrtr.com/iGo2-car-cord.

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, Libya, Lithuania, Malaysia, Maldives, Nepal, Netherlands, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Turkey, Uganda, Ukraine, United Arab Emirates.

Quantity

89,532 units