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FDA · Medical devicesClass I

Medical Depot Inc. medical device recall: iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen…

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96700
Recall initiated
Apr 11, 2025
Classified by FDA
May 9, 2025
Posted in Enforcement Report
May 21, 2025
Recalling firm
Medical Depot Inc.
Firm location
Port Washington, NY, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Apr 11, 2025. FDA classified it 28 days later, on May 9, 2025. Distribution reported by FDA: 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,… Medical Depot Inc. has 3 recalls in our records.

Recalled products (1)

  • Z-1727-2025 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.

    Codes / lots: 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.

    Quantity: 89,532 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96700
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.