Class II — Avanos Medical, Inc.
| Recalling firm | Avanos Medical, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The External Retention Bolster contained in the kit may be a larger diameter than the tube. |
| Product | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL |
| Quantity | 2652 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Chile. |
| Initiated | 2021-12-22 |
| Classified | 2022-02-07 |
| Terminated | 2023-08-15 |
| Recall number | Z-0565-2022 |
| 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 — Avanos Medical, Inc. (Z-0565-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89290/
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