Avanos Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
37 (13 Class I)
510(k) Clearances
8
Inspections
12
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1523-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software VMarch 19, 2025
Z-1525-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software March 19, 2025
Z-1521-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software VerMarch 19, 2025
Z-1527-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software VMarch 19, 2025
Z-1522-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software VerMarch 19, 2025
Z-1528-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 SoftwMarch 19, 2025
Z-1524-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software March 19, 2025
Z-1526-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 SoftwaMarch 19, 2025
Z-2422-2024Class IIMIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, RMay 31, 2024
Z-2036-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL OraMarch 4, 2024
Z-2037-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL OralMarch 4, 2024
Z-2035-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL OraMarch 4, 2024
Z-1187-2024Class IMIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-JejunaJanuary 16, 2024
Z-1186-2024Class IMIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube KJanuary 16, 2024
Z-0360-2024Class IIAVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suctiOctober 13, 2023
Z-2622-2023Class IICOOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels,August 1, 2023
Z-1685-2023Class IIAVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507April 24, 2023
Z-1686-2023Class IISMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537April 24, 2023
Z-1684-2023Class IIAVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509April 24, 2023
Z-1688-2023Class IIambIT Cassette Filter Male Luer, Product Code: 220266April 24, 2023

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