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Ohio Medical Corporation FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SClass IIMay 8, 2025Erroneous calibration values, potentially resulting in: as
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac Class IINov 16, 2021Increase in premature device failures

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