Avanos Medical, Inc.
FDA Regulatory Profile
Avanos Medical, Inc. appears in FDA public data with 57 recalls — including 13 Class I (most serious) —, 8 510(k) clearances, 12 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2336-2026, Class II) was initiated on April 30, 2026. Its most recent 510(k) clearance was granted on January 31, 2025.
Summary
- Total Recalls
- 57 (13 Class I)
- 510(k) Clearances
- 8
- Inspections
- 12
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2336-2026 | Class II | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | April 30, 2026 |
| Z-2348-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr P | April 30, 2026 |
| Z-2351-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr P | April 30, 2026 |
| Z-2340-2026 | Class II | Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Des | April 30, 2026 |
| Z-2343-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog | April 30, 2026 |
| Z-2341-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog | April 30, 2026 |
| Z-2344-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Num | April 30, 2026 |
| Z-2347-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr P | April 30, 2026 |
| Z-2337-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320 | April 30, 2026 |
| Z-2350-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr P | April 30, 2026 |
| Z-2335-2026 | Class II | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | April 30, 2026 |
| Z-2346-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Num | April 30, 2026 |
| Z-2334-2026 | Class II | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 | April 30, 2026 |
| Z-2338-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320 | April 30, 2026 |
| Z-2339-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312 | April 30, 2026 |
| Z-2352-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr P | April 30, 2026 |
| Z-2345-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Num | April 30, 2026 |
| Z-2333-2026 | Class II | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | April 30, 2026 |
| Z-2342-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog | April 30, 2026 |
| Z-2349-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr P | April 30, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - | January 31, 2025 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | October 25, 2024 |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | August 14, 2024 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | June 6, 2024 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | April 22, 2022 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | December 22, 2020 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | February 21, 2020 |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | June 4, 2019 |