DeVilbiss Healthcare LLC.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000021684 FEI 2515872
DeVilbiss Healthcare LLC. is a medical device manufacturer based in the United States, with 374 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I; EU Class IIa) and 7 FDA recalls as of 12 Nov 2026.
- Devices
- 374
- Registrations
- EUDAMEDFDA
- FDA recalls
- 73 ongoing
Registry facts
- Registries
- FDA GUDID 328
- FDA 510(k) 36
- EUDAMED 31
- Device classes
- FDA Class II 351
- FDA Class I 13
- EU Class IIa 10
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000021684
- FDA FEI 2515872
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What DeVilbiss Healthcare LLC. makes
DeVilbiss Healthcare LLC manufactures reusable and disposable respiratory and suction devices, including airway suction catheters, reusable nebulizing system delivery sets, and reusable surgical suction system collection containers. Their product line also covers portable and stationary oxygen concentrators, fixed-regulator oxygen refillable cylinders, and medical air compressors. The company provides line-powered general-purpose suction systems and portable oxygen delivery solutions like the iGo2.
DeVilbiss Healthcare’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Catalogue
Search and filter all 374 devicesShowing 1-50 of 374
Company details
- EUDAMED SRN
- US-MF-000021684
- FDA FEI number
- 2515872
- EUDAMED status
- Active
- EUDAMED registered name
- DeVilbiss Healthcare LLC
- Registered address
- 100, Devilbiss Dr, 15501, Somerset, United States
- Website
- www.devilbisshealthcare.com
- Phone
- +1 516 760 7712
- PRRC contact
- Jess Bohrer
FDA recalls
FDA recall records list 6 recalls initiated by DeVilbiss Healthcare LLC., the earliest on 2013-03-07 and the most recent on 2023-03-09. By recorded status: 3 ongoing and 3 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 2
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 9 Mar 2023 Z-1558-2023 Class II Ongoing The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
2022
- 18 Nov 2022 Z-0724-2023 Class II Ongoing 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, and the need for maintenance to certain components.
- 19 Sep 2022 Z-0229-2023 Class II Ongoing An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
2016
- 23 May 2016 Z-2246-2016 Class II Terminated A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
2014
- 13 May 2014 Z-1949-2014 Class III Terminated 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".
2013
- 7 Mar 2013 Z-2319-2013 Class II Terminated 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.
2011
- 11 Mar 2011 Z-2990-2011 Unclassified (pre-2012) Terminated Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.
Full distribution text
- 11 Mar 2011 Z-2990-2011 Unclassified (pre-2012) Terminated Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.
Frequently asked questions
How many devices does DeVilbiss Healthcare LLC. have in the registry?
The registry currently lists 374 devices for DeVilbiss Healthcare LLC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list DeVilbiss Healthcare LLC.'s devices?
Among its 50 most recently registered devices, DeVilbiss Healthcare LLC. has devices listed in EUDAMED (14 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DeVilbiss Healthcare LLC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for DeVilbiss Healthcare LLC.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for DeVilbiss Healthcare LLC.?
FDA recall records list 7 recalls initiated by DeVilbiss Healthcare LLC., the most recent initiated on 9 Mar 2023. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from DeVilbiss Healthcare LLC. in the registry?
The most recently registered devices listed for DeVilbiss Healthcare LLC. include Vacu-Aide, 5 liter Oxygen Concentrator, IGo2 and DeVilbiss 555DS.