FDA Device recall Z-2241-2023
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 by Davol, citing 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, inadequ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2241-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-25 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Davol |
| Distribution | US |
Product
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
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
Identifiers
| code_info | UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2241-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.