Davol, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2243-2023)

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 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 laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)

Product Classification:

Class II

Date Initiated: April 25, 2023

Date Posted: August 2, 2023

Recall Number: Z-2243-2023

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: 169 units

Code Information:

UDI-DI: (01)00801741201950(17)240528(10) Lot Number HUGT1609

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