Recall Z-1727-2025— Medical Depot Inc.

Name: FDA recall Z-1727-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Class I · Ongoing

Class I FDA medical device recall by Medical Depot Inc., initiated 2025-04-11. It names one FDA 510(k) clearance: K071397. 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.. Reason: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing..

Recalling firm: Medical Depot Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-04-11
Firm location: Port Washington, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K071397 — DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESSunrise Medical·cleared 2007-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.