# FDA recall Z-0565-2022

> **Avanos Medical, Inc.** · Class II · device recall initiated 2021-12-22.

## Product

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL

## Reason for recall

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

## Key facts

- **Recall number:** Z-0565-2022
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-22
- **Report date:** 2022-02-16
- **Termination date:** 2023-08-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2022

## Citation

> AI Analytics. FDA recall Z-0565-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0565-2022. Source: US FDA. Licensed CC0.

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