# FDA recall Z-0986-2024

> **Covidien LP** · Class II · device recall initiated 2023-11-16.

## Product

AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-  -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures  Model ABSTACK30

## Reason for recall

Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility

## Distribution

US Nationwide distribution in the states of CA, CO, FL, IL, TX.

## Key facts

- **Recall number:** Z-0986-2024
- **Recalling firm:** Covidien LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-16
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2024

## Citation

> AI Analytics. FDA recall Z-0986-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0986-2024. Source: US FDA. Licensed CC0.

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