FDA Medical devices recall ·
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1727-2025
- Date
- (initiated April 11, 2025)
- Company / brand
- Medical Depot Inc.
99 Seaview Blvd Fl 2, Port Washington, NY, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 89,532 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1727-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.