# FDA recall Z-2244-2023

> **Davol, Inc.** · Class II · device recall initiated 2023-04-25.

## Product

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 laparoscopic ventral hernia  repair.   Catalog Number: 5955460G (EU Only)

## 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

## 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.

## Key facts

- **Recall number:** Z-2244-2023
- **Recalling firm:** Davol, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-25
- **Report date:** 2023-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warwick, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2023

## Citation

> AI Analytics. FDA recall Z-2244-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2244-2023. Source: US FDA. Licensed CC0.

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