Devilbiss Healthcare recalls
Devilbiss Healthcare appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2023-05-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2013-10-09 to 2023-05-10 |
| By agency | FDA Device (6) |
| By classification | Class II (5), Class III (1) |
| By status | ongoing (3), terminated (3) |
| Distribution named in notices | CA, FL, IN, KY, LA, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, US, WI |
Recalls
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Device · Class II · 2023-05-10 · Devilbiss Healthcare
Reason: The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. - DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA Device · Class II · 2022-12-28 · Devilbiss Healthcare
Reason: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.… - 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
FDA Device · Class II · 2022-11-23 · Devilbiss Healthcare
Reason: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) - DeVilbiss Model 7305P-D Powered Suction Unit
FDA Device · Class II · 2016-07-27 · Devilbiss Healthcare
Reason: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. - DeVilbiss Model DV5x Series CPAP units
FDA Device · Class III · 2014-07-09 · Devilbiss Healthcare
Reason: A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". - DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6'…
FDA Device · Class II · 2013-10-09 · Devilbiss Healthcare
Reason: End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.