DeVilbiss Healthcare LLC FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 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	Reason	Class	Initiated
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-ARClass IIMar 9, 2023The instruction manual is being replaced with an updated ver	The instruction manual is being replaced with an updated version that is in alignment with labeling requiremen	Class IIDevices	Mar 9, 2023
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-QClass IINov 18, 2022The firm has received complaints of the device becoming hot.	The firm has received complaints of the device becoming hot. The firm has updated the user manual to include w	Class IIDevices	Nov 18, 2022
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12Class IISep 19, 2022An unapproved adhesive used to manufacture the accumulator t	An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathwa	Class IIDevices	Sep 19, 2022