Facility

DeVilbiss Healthcare LLC.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

4inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2515872
Establishment type	Manufacture Medical Device
Location	100 Devilbiss Dr SOMERSET, PA, US 15501
Registration status	Active · expires 2026
Parent company	Drive DeVilbiss Healthcare (owner-operator 10032050)
Brand names	DeVilbiss iFill Oxygen Cylinder Filling System (535 Series)

Activity by year

Recalls (6)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Generator, Oxygen, Portable
Product code CAW (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5440

Recalls & enforcement

Class IIOngoing2023-03-09
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Class IIOngoing2022-11-18
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 (105.8 degrees Fahrenheit), clarification on expected service life…
Class IIOngoing2022-09-19
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Class IITerminated2016-05-23
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Class IIITerminated2014-05-13
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".
Class IITerminated2013-03-07
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.

FDA inspections (4)

NAI2024-05-30
No Action Indicated · Compliance: Devices
OAI2022-08-17
Official Action Indicated · Compliance: Devices · citations posted
OAI2021-08-25
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-01-28
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2021-11-23
Warning Letter (opens in a new tab) · Somerset Pennsylvania

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Drive DeVilbiss Healthcare

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DeVilbiss Healthcare LLC. (FEI 2515872) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2515872-devilbiss-healthcare-llc/

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