Davol Inc.
United StatesFDA applicant, unverified FDA FEI 1000120505
Davol Inc. is a medical device manufacturer, with 480 devices listed in 4 registries (FDA Class II, III and I) and 8 FDA recalls as of 13 Nov 2026.
- Devices
- 480
- Registrations
- FDA
- FDA recalls
- 88 ongoing
Registry facts
- Registries
- FDA GUDID 429
- FDA 510(k) 50
- EUDAMED 3
- FDA PMA 1
- Device classes
- FDA Class II 454
- FDA Class III 21
- FDA Class I 5
- FDA recalls
- Identifiers
- FDA FEI 1000120505
- DUNS 001191048
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Davol Inc. makes
Davol Inc. manufactures synthetic and collagen-based surgical meshes for extra-gynaecological applications, including non-bioabsorbable, bioabsorbable, and antimicrobial variants, as well as composite-polymer blends. The company also produces laparoscopic delivery and positioning devices for mesh implantation, haemostatic collagen agents, and surgical mist irrigation tips.
The portfolio includes devices classified as Class II and Class III under FDA regulations, all of which are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 480 devicesShowing 1-50 of 480
Company details
- FDA FEI number
- 1000120505
- DUNS number
- 001191048
- Address
- 160 New Boston St, WOBURN, MA, 01801
- Phone
- +1(800)562-0027
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 3
- 2023 4
- 2024 0
- 2025 0
- 2026 1
2026
- 25 Mar 2026 Z-1896-2026 Class II Ongoing Potential for product to contain foreign matter, confirmed to be inspect fragments.
2023
- 25 Apr 2023 Z-2241-2023 Class II Ongoing Balloon may not inflate as intended. If the balloon
does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Full distribution text
- 25 Apr 2023 Z-2242-2023 Class II Ongoing Balloon may not inflate as intended. If the balloon
does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Full distribution text
- 25 Apr 2023 Z-2243-2023 Class II Ongoing Balloon may not inflate as intended. If the balloon
does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Full distribution text
- 25 Apr 2023 Z-2244-2023 Class II Ongoing Balloon may not inflate as intended. If the balloon
does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Full distribution text
- 25 Apr 2023 Z-2241-2023 Class II Ongoing Balloon may not inflate as intended. If the balloon
does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
2022
- 27 Jun 2022 Z-1457-2022 Class II Ongoing The device may potentially cause a fire, leading to a safety risk.
- 7 Jun 2022 Z-1304-2022 Class II Ongoing The product is not able to provide irrigation.
- 7 Jun 2022 Z-1305-2022 Class II Ongoing The product is not able to provide irrigation.
Frequently asked questions
How many devices does Davol Inc. have in the registry?
The registry currently lists 480 devices for Davol Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Davol Inc.'s devices?
Among its 50 most recently registered devices, Davol Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Davol Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Davol Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Davol Inc.?
FDA recall records list 8 recalls initiated by Davol Inc., the most recent initiated on 25 Mar 2026. 8 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 Davol Inc. in the registry?
The most recently registered devices listed for Davol Inc. include GalaFLEX 3DR FR3D02BD, GalaFLEX 3D SH3D02BD, GalaFLEX 3D SH3D04BD and GalaFLEX 3DR FR3D06BD.