Ventralight ST 4 — Class II medical device recall Z-2242-2023
Ongoing recall by Davol, Inc., reported 2023-08-02, distributed nationwide. Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair
| Recall number | Z-2242-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Davol, Inc., Warwick, RI, United States |
| Recall initiated | 2023-04-25 |
| Classified | 2023-07-27 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CL, CO, CZ, DE, ES, FR, GB, GR, HK, IE, IN, IT, NL, PT, SE, SK, ZA |
| Quantity | 1,599 units |
| UPC / GTIN / UDI-DI | 00801741031724 |
| Lot numbers | HUGS0922, HUGS2015, HUGS2020, HUGS2026, HUGS2044, HUGS2061, HUGS2076, HUGT1582, HUGU0748, HUGU0750 |
| Model numbers | 5955450 |
Product
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 laparoscopic ventral hernia repair. Catalog Number: 5955450
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2242-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.