Z-1727-2025Class I

iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to...

Name: Z-1727-2025 iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to...
Creator: Medical Depot Inc.
Published: 2025-04-11
License: https://open.fda.gov/license/

Medical Depot Inc. / initiated 2025-04-11 / Open, Classified / root cause: manufacturing process

FDA source

Medical Depot Inc. began a recall of 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 on 2025-04-11. FDA classified it as Class I and gives the reason as "Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1727-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-11
Posted: 2025-05-09
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.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1727-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09

Product code CAW

K071397Class IIDevilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSunrise Medical / cleared 2007-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)