FDA Enforcement Class I Ongoing

iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

Recall: Z-1727-2025 · Reported May 21, 2025

Enforcement

Recall Number
Z-1727-2025
Event ID
96700
Classification
Class I
Status
Ongoing
Product Type
Devices
Firm
Medical Depot Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
May 21, 2025
Initiation Date
April 11, 2025
Classification Date
May 9, 2025
Address
99 Seaview Blvd Fl 2, Port Washington, NY, 11050-4606, United States

Description

iGo¿2 DC Car Adapter to be used with iGo¿2 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.

Code Info

DC Cord Code Info: Catalog No. DV6X-619; UDI 885304020585; Cord Revision: Rev E; Lot No. beginning with 2023-01-01 through 2024-12-31. iGo2 Portable Oxygen Concentrator Systems Code Info: Catalog No. 125D, 125D-XB, 125D-BT, 125D-BT-XB, 125D-ARYA-XB; UDI 885304022237, 885304032250, 885304033257, 885304033240, 885304033516; Lot No. D23125001DS to D23A26121DS, D23706001DA to D23B16056DA, F23B06001DS to F25108143DS, F23313001DH to F25109259DH, F24212001DA to F25217150DA.

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