iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allow...
FDA Recall #Z-1727-2025 — Class I — April 11, 2025
Product 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 for Recall
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Recalling Firm
Medical Depot Inc. — Port Washington, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product 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, 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.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated