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Avanos Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
57 (13 Class I)
510(k) Clearances
8
Inspections
12
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2338-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320April 30, 2026
Z-2348-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PApril 30, 2026
Z-2336-2026Class IIProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316April 30, 2026
Z-2339-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312April 30, 2026
Z-2341-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/CatalogApril 30, 2026
Z-2345-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog NumApril 30, 2026
Z-2337-2026Class IIProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320April 30, 2026
Z-2350-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PApril 30, 2026
Z-2351-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PApril 30, 2026
Z-2343-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/CatalogApril 30, 2026
Z-2340-2026Class IIProduct Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product DesApril 30, 2026
Z-2334-2026Class IIBrand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320April 30, 2026
Z-2333-2026Class IIBrand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320April 30, 2026
Z-2335-2026Class IIProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312April 30, 2026
Z-2346-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog NumApril 30, 2026
Z-2352-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PApril 30, 2026
Z-2342-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/CatalogApril 30, 2026
Z-2344-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog NumApril 30, 2026
Z-2347-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PApril 30, 2026
Z-2349-2026Class IIProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PApril 30, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap -January 31, 2025
K241185CORGRIP* SR NG/NI Tube Retention SystemOctober 25, 2024
K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)August 14, 2024
K240965CORTRAK* 2 Enteral Access System (20-0950)June 6, 2024
K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)April 22, 2022
K203066COOLIEF Cooled Radiofrequency Kit AdvancedDecember 22, 2020
K192491Coolief Radiofrequency Generator (CRG) SystemFebruary 21, 2020
K191340CORTRAK* 2 Equilateral Enteral Access SystemJune 4, 2019