Avanos Medical, Inc.
5405 Windward Parkway, Alpharetta, GA, US
Registered product codes
61 product codes
Recent MDR events
6,135 on file
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026Malfunction3011270181-2026-00140
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026Malfunction3011270181-2026-00141
- ENFit PVC Feeding Tube Purple 8Fr 60cmJul 31, 2026Malfunction3011270181-2026-00142
- ENFit PU Feeding Tube PurpleJul 30, 2026Malfunction3011270181-2026-00143
- CORTRAK 2 NG/NI Feed Tube, Electro-Stylet, ENFitJul 29, 2026Malfunction9611594-2026-00209
- CORTRAK 2 NG/NI Feed Tube, Electro-Stylet, ENFitJul 29, 2026Malfunction9611594-2026-00210
- CORTRAK 2 NG/NI Feed Tube, Electro-Stylet, ENFitJul 29, 2026Malfunction9611594-2026-00208
- ENFit PU Feeding Tube Orange 6.5Fr 40cmJul 29, 2026Malfunction3011270181-2026-00132
- NEOMED Nasogastric/Orogastric Feeding TubesJul 29, 2026Malfunction3011270181-2026-00121
- NEOMED Nasogastric/Orogastric Feeding TubesJul 29, 2026Malfunction3011270181-2026-00137
Recalls
57 on file
- Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗ - Open, ClassifiedJun 5, 2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
View FDA record ↗
Compliance history
Matched by FEI 3011270181.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 15, 2023
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 15, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Dec 15, 2023
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(a)Dec 15, 2023
Lack of or inadequate procedures
- 21 CFR 820.198(a)Dec 15, 2023
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.