Parietex Composite Mesh Polyester with Absorbable Collagen Film — Class II medical device recall Z-1183-2023
Ongoing recall by Covidien, LP, reported 2023-03-08, distributed in CA, GA, NY. Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, ero
| Recall number | Z-1183-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2023-01-11 |
| Classified | 2023-02-26 |
| Reported by FDA | 2023-03-08 |
| Distributed | CA, GA, NY |
| Countries outside the US | BE, CH, DE, ES, FR, GB, IL, JP, LU, RO |
| Quantity | 53 units |
| Lot numbers | PVE0194M |
| Model numbers | PCO2H3 |
Product
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
Reason for recall
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
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-1183-2023. 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.