Class II — Covidien, LP
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| 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 |
| Quantity | 53 units |
| Distribution | US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom. |
| Initiated | 2023-01-11 |
| Classified | 2023-02-26 |
| Recall number | Z-1183-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien, LP (Z-1183-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91567/
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