Class 1 Device Recall iGo2 DC Car Adapter

• Date Initiated by Firm: April 11, 2025
• Date Posted: May 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1727-2025
• Recall Event ID: 96700
• 510(K)Number: K071397
• Product Classification: Generator, oxygen, portable - Product Code CAW
• 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.
• 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.
• Recalling Firm/ Manufacturer: Medical Depot Inc.; 99 Seaview Blvd Fl 2; Port Washington NY 11050-4606
• For Additional Information Contact: Susan Scott; 801-931-1050
• Manufacturer Reason for Recall: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAW