Avanos Cortrak 2 Enteral Access System — Class I medical device recall Z-1032-2022
Terminated recall by Avanos Medical, Inc., reported 2022-05-25, distributed nationwide. Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device imme
| Recall number | Z-1032-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2022-03-21 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2024-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, DE, GB, IE, IN, JP, KW, MY, NL, NZ, PA, SG |
| Quantity | 721 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00350770472010, 00350770472065, 10680651472011, 10680651472066 |
Product
Avanos Cortrak 2 Enteral Access System (EAS)
Reason for recall
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
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-1032-2022. 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.