Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

FDA Recall Z-1980-2025 · Posted 2025-06-13

Recalling FirmOhio Medical Corporation
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2025-05-08
Product Quantity36 units

Reason for Recall

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

Firm Action

Ohio Medical issued a Field Safety Notice to its consignees on 05/08/2025 followed by telephone calls on 05/13/2025. The notice explained the problem with the device, potential risk, and requested the devices be returned for correction. The notice further stated: "The Field Safety Notice is communicated to all impacted customers and is communicated to competent authorities in the affected markets. Receivers should pass this FSN on to all persons with a need to be advised from within your organization or to any organization where the potentially affected products have been supplied. Please consider end users and others within the supply chain in the circulation of this notice."

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑