# FDA recall Z-1183-2023

> **Covidien, LP** · Class II · device recall initiated 2023-01-11.

## 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

## 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.

## Key facts

- **Recall number:** Z-1183-2023
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-11
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2023

## Citation

> AI Analytics. FDA recall Z-1183-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1183-2023. Source: US FDA. Licensed CC0.

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