Food, drugs, devices › Avanos Medical, Inc.
Device recall: Avanos Cortrak 2 Enteral Access System (EAS)
FDA enforcement event 89997 is a device recall by Avanos Medical, Inc. of Alpharetta, GA, initiated 21 Mar 2022 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 9 Sep 2024. Initiation: voluntary: firm initiated. Avanos Medical, Inc. has 19 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Avanos Medical, Inc., Alpharetta, GA.
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."
Distribution
"Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1032-2022 | Avanos Cortrak 2 Enteral Access System (EAS) | 721 devices | Class I | Terminated | 25 May 2022 |
Context
Other enforcement events for Avanos Medical, Inc.
All 19 events for Avanos Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.