Agency classClass IOur severity:Severe FDA (Devices)·Z-1727-2025·Announced 2025-05-21

iGo2 DC Car Adapter Recall: Overheating and Housing Deformation Risk

Medical Depot Inc. is recalling 89,532 units of the iGo2 DC Car Adapter used with iGo2 Portable Oxygen Concentrator Systems. The DC power supply housing may become excessively hot to the touch and deform, posing a burn and fire hazard.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall with a structural defect (overheating power supply housing) that poses risk of thermal injury and fire. Although no injuries are reported in the source, Class I designation and the burn/fire hazard mechanism meet the Severe criterion.

Plain-English summary

Medical Depot Inc. is recalling the iGo2 DC Car Adapter (Catalog No. DV6X-619) used with iGo2 Portable Oxygen Concentrator Systems worldwide. The power cord allows users to operate the oxygen concentrator in a vehicle. A total of 89,532 units are affected.

The DC power supply housing in the adapter may become hot to the touch and deform the plastic housing. This defect creates a risk of thermal injury and potential fire hazard to users.

The recall affects adapters with Lot Numbers beginning with 2023-01-01 through 2024-12-31 and UDI 885304020585. The affected oxygen concentrator systems have Catalog Nos. 125D, 125D-XB, 125D-BT, 125D-BT-XB, and 125D-ARYA-XB, with corresponding UDI numbers and specific lot ranges. Distribution is worldwide, including the United States and over 50 countries.

Consumers should stop using the affected DC Car Adapter immediately. For instructions on replacement or repair, users should contact Medical Depot Inc. or their healthcare provider.

The recalled product

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.
Manufacturer: Medical Depot Inc.
Category: Medical Device — Oxygen Delivery Accessory
Hazard: burn-injury
fire
overheating
Affected units: 89,532

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

DC Cord Code Info: Catalog No. DV6X-619
UDI 885304020585
Cord Revision: Rev E
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

Distributed nationwide across the United States.

Same manufacturer · Medical Depot Inc.

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