Recall Register

Avanos Medical, Inc.: FDA recalls

FDA enforcement reports name Avanos Medical, Inc. as the recalling firm in 19 events. The events have 57 product records. The recalls started from 2019 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

19 events, newest first.

FDA enforcement events of Avanos Medical, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
30 Apr 2026Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320DeviceClass II20Ongoing
19 Mar 2025Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: NoDeviceClass I8Ongoing
31 May 2024MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with…DeviceClass II1Ongoing
4 Mar 2024NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product…DeviceClass III3Ongoing
16 Jan 2024MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c)…DeviceClass I2Ongoing
13 Oct 2023AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilationDeviceClass II1Ongoing
1 Aug 2023COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning…DeviceClass II1Completed
24 Apr 2023AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509DeviceClass II5Terminated
3 Feb 2023Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251DeviceClass II1Terminated
3 Feb 2023BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.DeviceClass I2Terminated
14 Sep 2022Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessoryDeviceClass II1Terminated
21 Mar 2022Avanos Cortrak 2 Enteral Access System (EAS)DeviceClass I1Terminated
22 Dec 2021MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULLDeviceClass II2Terminated
22 Nov 2021BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single UseDeviceClass II3Terminated
16 Oct 2020CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV ConnectorDeviceClass II1Terminated
29 Jul 2020AVANOS MIC-KEY SF Gastrostomy Feeding TubeDeviceClass II1Terminated
16 Mar 2020CORFLO Percutaneous Endoscopic Gastrostomy (PEG)KitDeviceClass II1Terminated
5 Nov 2019Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code 109838302.DeviceClass II1Terminated
8 Oct 2019CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Avanos Medical, Inc.: events for each product type
TypeEvents
Device19
Avanos Medical, Inc.: events in each class
ClassEvents
Class II14
Class I4
Class III1
Share of the events of the firm in Class I
21%
Share of all events on the register in Class I
18%
Events with the status Ongoing
6

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Avanos Medical, Inc., by the year that the recall started. The largest year is 2023, with 5 events.

Official channels

Cite this page

Recall Register. Avanos Medical, Inc.: FDA recalls. https://recallregister.com/firm/avanos-medical-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
GA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Avanos Medical, Inc. have?
Class II: 14 events. Class I: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Avanos Medical, Inc.?
FDA event 98907, which the firm started on 30 Apr 2026. The first product in the record is: Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
How many FDA recalls of Avanos Medical, Inc. have the status Ongoing?
6 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.