CLASS I Device recall · Reported 25 May 2022 · FDA Enforcement Report

Avanos Cortrak 2 Enteral Access System (EAS) recalled by Avanos Medical

Avanos Medical is recalling Avanos Cortrak 2 Enteral Access System (EAS), distributed nationwide in the US. The recall was initiated on 21 Mar 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 3) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers 4) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers

Quantity recalled721 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1032-2022
FDA event ID: 89997
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class I
Status: Terminated
Recall initiated: 21 Mar 2022
FDA classified: 13 May 2022
Reported: 25 May 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Mar 2022	Recall initiated by company
13 May 2022	Classified by FDA	+53 days
25 May 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Avanos Cortrak 2 Enteral Access System (EAS)

Where it was distributed

Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Is Avanos Cortrak 2 Enteral Access System (EAS) recalled?

Yes. Avanos Medical recalled Avanos Cortrak 2 Enteral Access System (EAS) on 21 Mar 2022. The recall is Class I and its status is Terminated. Recall number Z-1032-2022.

Why was it recalled?

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.

Which lots are affected?

1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 3) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers 4) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers

Where was it sold?

Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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