Warwick, RI, United States
Davol, Inc. recalls
4 recalls recorded since 2018, most recently on 25 March 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 March 2026
- Reason
- Potential for product to contain foreign matter, confirmed to be inspect fragments.
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1896-2026
- Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Ongoing Class II Medical devices
- Recall started
- 25 April 2023
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2243-2023, Z-2244-2023, Z-2242-2023, Z-2241-2023
- Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscop
- Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscop
- Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparosc
- Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Ongoing Class II Medical devices
- Recall started
- 27 June 2022
- Reason
- The device may potentially cause a fire, leading to a safety risk.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1457-2022
- X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Ongoing Class II Medical devices
- Recall started
- 7 June 2022
- Reason
- The product is not able to provide irrigation.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1305-2022, Z-1304-2022
- HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
- HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.