Avanos Medical, Inc.
Avanos Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2025, with 57 FDA device recalls on record.
Top product codes for Avanos Medical, Inc.
FDA recalls by Avanos Medical, Inc.
10 most recent of 57- Z-2337-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
- Z-2343-2026 — Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
- Z-2338-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
- Z-2348-2026 — Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
- Z-2346-2026 — Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
- Z-2334-2026 — Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
- Z-2344-2026 — Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
- Z-2335-2026 — Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
- Z-2339-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
- Z-2352-2026 — Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Avanos Medical, Inc.
- K243572 — Game Ready system (550500-04) +11 more
- K241185 — CORGRIP* SR NG/NI Tube Retention System
- K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- K240965 — CORTRAK* 2 Enteral Access System (20-0950)
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
- K192491 — Coolief Radiofrequency Generator (CRG) System
- K191340 — CORTRAK* 2 Equilateral Enteral Access System
Data sourced from openFDA. This site is unofficial and independent of the FDA.