RecallRadar

FDA Device recall Z-1032-2022

Avanos Cortrak 2 Enteral Access System (EAS)

On 2022-05-25 the FDA classified a Class I recall of Avanos Cortrak 2 Enteral Access System (EAS) by Avanos Medical, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1032-2022
ClassificationClass I
Statusterminated
Initiated2022-03-21
Published2022-05-25
Last updated2026-09-13 11:56 UTC
CompanyAvanos Medical
DistributionUS

Product

Avanos Cortrak 2 Enteral Access System (EAS)

Reason

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.

Identifiers

code_info
1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Cod…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1032-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.