Enterix Inc.
United StatesFDA applicant, unverified FDA FEI 3003224146
Enterix Inc. is a medical device manufacturer, with 19 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 3 FDA recalls as of 13 Nov 2026.
- Devices
- 19
- Registrations
- FDA
- FDA recalls
- 31 ongoing
Registry facts
- Registries
- FDA GUDID 16
- FDA 510(k) 3
- Device classes
- FDA Class II 19
- FDA recalls
- Identifiers
- FDA FEI 3003224146
- DUNS 002224009
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Enterix Inc. makes
Enterix Inc. manufactures in vitro diagnostic (IVD) devices for faecal occult blood testing, including rapid immunochemical test (ICT) kits for clinical use, home-use faecal specimen collection kits, and reagent and control solutions. Their products are designed to detect hidden blood in stool samples, supporting colorectal cancer screening and monitoring.
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the Unique Device Identifier (UDI) system. These products are listed in the FDA’s regulatory databases and are intended for use in the United States.
Catalogue
Search and filter all 19 devicesCompany details
- FDA FEI number
- 3003224146
- DUNS number
- 002224009
- Address
- 236 Fernwood Ave, EDISON, NJ, 08837
- xx@xx.xx
- Phone
- 18005313681
FDA recalls
FDA recall records list 3 recalls initiated by ENTERIX INC., the earliest on 2008-10-03 and the most recent on 2025-09-17. By recorded status: 1 ongoing and 2 terminated. The reasons filed fall into these groups: performance or accuracy 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 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 17 Sep 2025 Z-0725-2026 Class II Ongoing InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Full distribution text
- 17 Sep 2025 Z-0725-2026 Class II Ongoing InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
2020
- 8 Oct 2020 Z-0590-2021 Class II Terminated Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy
2008
- 3 Oct 2008 Z-0480-2009 Unclassified (pre-2012) Terminated False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.
Frequently asked questions
How many devices does ENTERIX INC. have in the registry?
The registry currently lists 19 devices for ENTERIX INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ENTERIX INC.'s devices?
Among its 19 most recently registered devices, ENTERIX INC. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ENTERIX INC.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for ENTERIX INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ENTERIX INC.?
FDA recall records list 3 recalls initiated by ENTERIX INC., the most recent initiated on 17 Sep 2025. 1 of them is 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 ENTERIX INC. in the registry?
The most recently registered devices listed for ENTERIX INC. include InSure FIT 01, InSure® ONE™ 01, InSure ONE and !NSURE FECAL OCCULT BLOOD TEST.