This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Names: iGo2 POC car DC Power Cord Adapter
- Model DV6X-619 Rev E car charger cords
- Unique Device Identifier (UDI)/Model:
- Car Charger Cord Adapter – 885304020585
- iGo2 Portable Oxygen Concentrator System – 885304022237, 885304032250, 885304033257, 885304033240, 885304033516
- Lot/Serial Numbers: Lots beginning with 2023-01-01 through 2024-12-31; and/or Car Charger Cords labeled “Rev E”
What to Do
- Identify any inventory in your possession using the following identifiers:
- Model DV6X-619 Rev E car charger cords of lot numbers 2023-01-01 through 2024-12-31.
- The serial number on the corresponding iGo2 POC unit.
- Inspection and confirmation of the condition of the car charger cord adapter can be easily performed by unscrewing the metal cap.
- If it reveals the internal spring next to the cap, this configuration is being recalled.
- If it reveals the fuse next to the cap, this configuration is not recalled.
- Destroy all affected car charger cords by cutting the cord with wire-cutters or unscrewing the cap and then discarding the car charger parts.
On April 11, 2025, Drive DeVilbiss Healthcare sent all affected customers an Urgent Notice Medical Device Recall letter recommending the following actions:
- To obtain replacement car charger cords, go to www.recallrtr.com/iGo2DME and input the Verification Code provided in the letter. Using that code on the website, you will be able to:
- Confirm the quantity of affected car charger cords in your possession.
- Order replacement products.
- Fill out a web form to acknowledge receipt of and compliance with this recall.
- Contact all users who purchased or rented an affected unit and provide them notice of and instructions for compliance with this recall.
- As these items are typically rented to end users, it is recommended that you continue to check units as they return from rental use.
- Until replacement car charger cords are available, it is recommended:
- If you do not have inventory with unaffected car chargers, distribute the iGo2 POC system without the car charger as this is a non-critical accessory.
- Advise end users that if they must use the car charger before it has been inspected and/or replaced, they should ensure the battery is fully charged and/or flow setting is at or below 3 lpm.
Reason for Recall
Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter, a non-critical accessory to the iGo2 Portable Oxygen Concentrator (POC), due to complaints of the DC power cord being hot to the touch and/or melting while being used.
The iGo2 POC is a DC-powered, variable motor/compressor speed oxygen concentrator that can be operated from an AC, DC, or battery power source.
The use of affected product may cause serious adverse health consequences, including thermal injuries and/or burns to the fingers and/or hands.
There have been two reported injuries. There have been no reports of death.
Device Use
iGo2 DC Car Adapter is used with iGo2 Portable Oxygen Concentrator Systems. The DC power adapter is a non-critical accessory to the iGo2 Portable Oxygen Concentrator (POC). It allows the user to operate their iGo2 POC from a DC power supply, such as the DC port in a vehicle. Under normal operating conditions, the DC power cord will power the unit while concurrently charging the device internal battery.
Contact Information
Customers in the U.S. with questions about this recall should contact Drive DeVilbiss Healthcare at 1-(888)-770-7017, Monday to Friday, from 7:30 a.m. to 5:00 p.m. Central Time.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
