Inovo, Inc: Medical Device Recall in 2018 - (Recall #: Z-0407-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Product Classification:

Class II

Date Initiated: October 9, 2017

Date Posted: January 31, 2018

Recall Number: Z-0407-2018

Event ID: 78883

Reason for Recall:

Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).

Status: Terminated

Product Quantity: 13,140 units

Code Information:

UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated