iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allow...
FDA Device Recall #Z-1727-2025 — Class I — April 11, 2025
Recall Summary
| Recall Number | Z-1727-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | April 11, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medical Depot Inc. |
| Location | Port Washington, NY |
| Product Type | Devices |
| Quantity | 89,532 units |
Product Description
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.
Reason for Recall
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Distribution Pattern
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 / 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.
Other Recalls from Medical Depot Inc.
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|---|---|---|---|
| Z-2354-2024 | Class II | Nitro Glide Knee Walker-offers users recovering... | Jun 14, 2024 |
| Z-2355-2024 | Class II | Nitro Glide Knee Walker-offers users recovering... | Jun 14, 2024 |
| Z-2104-2016 | Class II | Universal Quick Adjust under the following labe... | Feb 17, 2016 |
| Z-2106-2016 | Class II | Direct Supply aluminum crutch, adult, 1 pair pe... | Feb 17, 2016 |
| Z-2103-2016 | Class II | Universal aluminum crutch, 1 pair per case A... | Feb 17, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.