FDA recall Z-1980-2025

Product

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-05-08

Report date

2025-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2025