Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Avanos Medical medical devices: approvals, recalls and adverse events

Stock: AVNS. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

114

18 class I

Adverse event reports

8,986

152 deaths reported

How many recalls does Avanos Medical have?

Avanos Medical has 114 recalled medical device products in 29 recall actions in the records, 18 of them class I (the most serious kind). The newest recall started on Apr 30, 2026. In 2025 it had 8 recalled products.

How many medical devices has Avanos Medical had cleared or approved?

23 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Jan 31, 2025.

How many adverse event reports name Avanos Medical devices?

8,986 reports in total: 152 deaths, 1,420 injuries and 7,386 malfunctions were reported. 719 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2025	1	0	0	0
2024	3	0	0	0
2022	1	0	0	0
2020

Newest clearances and approvals

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand...
K243572 · 510(k) clearance · Jan 31, 2025
CORGRIP* SR NG/NI Tube Retention System
K241185 · 510(k) clearance · Oct 25, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · 510(k) clearance · Aug 14, 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · 510(k) clearance · Jun 6, 2024
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · 510(k) clearance · Apr 22, 2022
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · 510(k) clearance · Dec 22, 2020
Coolief Radiofrequency Generator (CRG) System
K192491 · 510(k) clearance · Feb 21, 2020
CORTRAK* 2 Equilateral Enteral Access System
K191340 · 510(k) clearance · Jun 4, 2019
ON-Q* Pump with Bolus
K181360 · 510(k) clearance · Mar 22, 2019
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K180646 · 510(k) clearance · Jun 27, 2018

Devices with the most adverse event reports

By product code, all years

Tubes, Gastrointestinal (And Accessories) (KNT, class 2)3,278
Catheters, Suction, Tracheobronchial (BSY, class 1)2,171
Pump, Infusion, Elastomeric (MEB, class 2)1,012
Tube, Tracheal (W/Wo Connector) (BTR, class 2)819
Tube, Gastro-Enterostomy (KGC, class 2)730
Tube, Feeding (FPD, class 2)212
Catheter And Tip, Suction (JOL, class 2)121
Catheter, Conduction, Anesthetic (BSO, class 2)107
Enteral Syringes With Enteral Specific Connectors (PNR, class 2)96

All device makers and procedures · AVNS stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to AVNS with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	20	0	1,159	6
2025	8	8	719	9
2024	6	2	804	12
2023	10	2	803	16
2022	2	1	737	21
2021	5	0	488	9
2020	3	0	726	17
2019	3	0	783	18
2018	3	0	1,147	18
2017	10	0	468	18
2016	3	0	512	6
2015	36	0	581	2
2014	5	5	59	-

Newest recalls

Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feedi
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Class II · Apr 30, 2026 · Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.