Abbvie Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000014055
Abbvie Inc. is a medical device manufacturer based in the United States, with 59 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class IIa and I) and 4 FDA recalls as of 14 Nov 2026.
- Devices
- 59
- Registrations
- EUDAMED
- FDA recalls
- 4
Registry facts
- Registries
- FDA GUDID 37
- EUDAMED 15
- FDA 510(k) 7
- Device classes
- FDA Class I 25
- FDA Class II 18
- EU Class IIa 9
- EU Class I 6
- FDA Unclassified 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Allergan Pharmaceuticals International Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000014055
- DUNS 078458370
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Allergan Pharmaceuticals International LimitedIE
What Abbvie Inc. makes
The company manufactures reusable personal device holders for medical accessories, including ENFit-compatible connectors for feeding tubes (jejunostomy, nasoenteral, and gastrostomy) and Y-connectors for tube management. It also produces closed-ended one-piece intestinal ostomy bags and subcutaneous self-injection aids. Additionally, the portfolio includes fitted vests for medical device support, such as vest-based infusion systems.
These devices are regulated under Class I and Class II (including Class IIa) classifications, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) registry. The company is based in the United States.
Catalogue
Search and filter all 59 devicesShowing 1-50 of 59
Company details
- EUDAMED SRN
- US-MF-000014055
- DUNS number
- 078458370
- EUDAMED status
- Active
- EUDAMED registered name
- AbbVie Inc.
- Registered address
- 1 North Waukegan Road, 60064, North Chicago, Illinois, United States
- Website
- abbvie.com
- devices@abbvie.com
- Phone
- +1 800 255-5162
- PRRC contact
- Andrew Aube
FDA recalls
FDA recall records list 4 recalls initiated by ABBVIE INC., the earliest on 2016-11-22 and the most recent on 2017-04-27. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use. 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 3
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 27 Apr 2017 Z-2176-2017 Class II Terminated —
Full distribution text
- 27 Apr 2017 Z-2177-2017 Class II Terminated PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Full distribution text
- 27 Apr 2017 Z-2178-2017 Class II Terminated PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Full distribution text
- 27 Apr 2017 Z-2176-2017 Class II Terminated —
2016
- 22 Nov 2016 Z-0786-2017 Class II Terminated AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
Frequently asked questions
How many devices does ABBVIE INC. have in the registry?
The registry currently lists 59 devices for ABBVIE INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ABBVIE INC.'s devices?
Among its 50 most recently registered devices, ABBVIE INC. has devices listed in EUDAMED (10 devices), FDA 510(k) (3 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ABBVIE INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ABBVIE INC.'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 ABBVIE INC.?
FDA recall records list 4 recalls initiated by ABBVIE INC., the most recent initiated on 27 Apr 2017. 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 ABBVIE INC. in the registry?
The most recently registered devices listed for ABBVIE INC. include myAbbVieCare Android, myAbbVieCare Patient Portal, myAbbVieCare Apple (iOS) and AbbVie ENFit Y-Connector 15 FR.