Davol, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2241-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

Product Classification:

Class II

Date Initiated: April 25, 2023

Date Posted: August 2, 2023

Recall Number: Z-2241-2023

Event ID: 92213

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1188 units US; 5 units OUS

Code Information:

UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated