AVNS ambIT System — Class II medical device recall Z-1685-2023
Terminated recall by Avanos Medical, Inc., reported 2023-06-14, distributed nationwide. Some of the ambIT kits were potentially distributed without an air in-line filter.
| Recall number | Z-1685-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2023-04-24 |
| Classified | 2023-06-06 |
| Reported by FDA | 2023-06-14 |
| Terminated | 2024-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Lot numbers | 30174128, 30177647 |
Product
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Reason for recall
Some of the ambIT kits were potentially distributed without an air in-line filter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1685-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.