# FDA recall Z-2422-2024

> **Avanos Medical, Inc.** · Class II · device recall initiated 2024-05-31.

## Product

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT);  and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers:    1.  0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit;  2.  0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit;  3.  0270-18- - 18 Fr, all sizes - Non-ENFit;  4.  0270-22- - 22 Fr, all sizes - Non-ENFit;  5.  8270-14- - 14 Fr, all sizes (ENFit);  6.  8270-16- - 16 Fr, all sizes (ENFit);  7.  8270-18- - 18 Fr, all sizes (ENFit);  8.  8270-22- - 22 Fr, all sizes  (ENFit).

## Reason for recall

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

## Distribution

Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.

## Key facts

- **Recall number:** Z-2422-2024
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-31
- **Report date:** 2024-07-31

- **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-2422-2024

## Citation

> AI Analytics. FDA recall Z-2422-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2422-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*