FDA Medical Device Recalls (openFDA)
Medical Depot Inc.: iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
- Recall number
- Z-1727-2025
- Recalling firm
- Medical Depot Inc.
- Product
- iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
- Status
- Open, Classified
- Initiated
- 2025-04-11
- Posted
- 2025-05-09
- Terminated
- not on file
- Reason
- Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- Root cause
- Nonconforming Material/Component
- Action
- An URGENT NOTICE MEDICAL DEVICE RECALL dated 4/11/25 was emailed to consignees. The recall notification instructs consignees on how to identify affected devices in their possession, destroy the affected charger cord, and provides instructions on how to obtain a replacement charger cord through Drive Devilbiss. If product was further distributed, consignees are to contact their customers; Devilbiss has a draft recall notification and recall website available for their consignees who further distributed product. For those units that are rentals, Devilbiss recommends that consignees check devices as they return from rental use. Dan Hinkbein is available to assist consignees who distributed affected devices fulfill recall actions and can be contacted at dan.hinkebein@realtimeresults.net. Consignees with any issues or questions can call Drive Devilbiss Healthcare at 888-770-7017 Monday through Friday from 7:30 AM to 5:00 PM CST. Questions can also be emailed to iGo2-car-cord@realtimeresults.net. The firm has set up a website for this recall event at www.recallrtr.com/iGo2-car-cord.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071397"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3002997602
- Firm city
- Port Washington
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28