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Avanos Medical, Inc.

Last updated September 17, 2026

What Avanos Medical, Inc. makes

Avanos Medical produces enteral feeding devices, including gastrostomy buttons, jejunostomy tubes, nasogastric feeding tubes, and gastrostomy tubes, as well as feeding tube kits. The company also manufactures peripheral anaesthesia catheter sets, suction system catheters, elastomeric infusion pump systems, and single-use percutaneous radio-frequency ablation probe cannulae. Additional products include ENFit extension sets and a closed suction system for medical use.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Avanos Medical, Inc. primarily manufacture?

Avanos Medical, Inc. specializes in enteral feeding solutions and related medical devices. Their portfolio includes gastrostomy buttons, jejunostomy tubes, nasogastric feeding tubes, gastrostomy tubes, and feeding tube kits, which are essential for patients requiring long-term nutritional support. They also produce peripheral anaesthesia catheter sets, suction system catheters, elastomeric infusion pump systems, and single-use percutaneous radio-frequency ablation probe cannulae, catering to diverse clinical needs.

Where is Avanos Medical, Inc. based, and how does this affect its regulatory compliance?

Avanos Medical, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA’s Class I and Class II categories, reflecting varying levels of regulatory oversight based on risk. Since the U.S. is the primary market, compliance with FDA requirements—such as UDI listing—is critical for market access and traceability.

Which regulatory registries list Avanos Medical’s devices, and why is this important?

Avanos Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is vital because UDIs ensure standardized identification of medical devices, improving tracking, recall management, and post-market surveillance. Listing in this database helps healthcare providers, regulators, and supply chain partners verify device authenticity and compliance with FDA requirements.

How are Avanos Medical’s devices classified under FDA regulations, and what does this mean for their use?

Avanos Medical’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, with Class II devices often requiring pre-market notifications (510(k)) to demonstrate compliance with FDA standards before commercialization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 5405 Windward Parkway, Alpharetta, GA, 30004
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011270181
DUNS Number: —

Catalogue (6247)

Page 5 of 125

Device	Model / Reference	Registries	Class	Status
Halyard	11022	FDA UDI	Class II	Unknown
Avanos	35112	FDA UDI	Class II	Active
Avanos	182122	FDA UDI	Class II	Active
Halyard	47443	FDA UDI	Class II	Active
Game Ready Back Wrap - Rental	590500-03-RN	FDA UDI	Class II	Active
Halyard	25909	FDA UDI	Class II	Active
Avanos	44117	FDA UDI	Class II	Active
Game Ready	510100-03	FDA UDI	Class II	Active
Avanos	98497	FDA UDI	Class II	Active
Med4 Elite	650550	FDA UDI	Class II	Active
Avanos	20-5431AIV2	FDA UDI	Class II	Active
Avanos	7120-18-4.0	FDA UDI	Class II	Active
Avanos	47932	FDA UDI	Class II	Active
Game Ready	510160	FDA UDI	Class II	Active
Avanos	H9386102EN	FDA UDI	Class I	Active
Avanos	47109	FDA UDI	Class II	Active
Halyard	94852	FDA UDI	Class II	Active
Game Ready	520602-03	FDA UDI	Class II	Active
ON-Q* Pain Relief System	13620	FDA UDI	Class II	Active
Avanos	B30511	FDA UDI	Class I	Unknown
Avanos	44577	FDA UDI	Class II	Active
Avanos	95461	FDA UDI	Class II	Active
Halyard	12545	FDA UDI	Class II	Active
Avanos	44110	FDA UDI	Class II	Active
Avanos	94960	FDA UDI	Class II	Active
Avanos	95495	FDA UDI	Class II	Active
Halyard	12483	FDA UDI	Class II	Active
Avanos	47949	FDA UDI	Class II	Active
Avanos*	181A140	FDA UDI	Class II	Unknown
Avanos	92424	FDA UDI	Class I	Active
Halyard	94949	FDA UDI	Class II	Active
Halyard	97573	FDA UDI	Class II	Unknown
Avanos	94811	FDA UDI	Class II	Active
Avanos	182A36	FDA UDI	Class II	Unknown
Halyard	48753	FDA UDI	Class I	Active
Avanos	44590	FDA UDI	Class II	Active
Halyard	47051	FDA UDI	Class II	Active
Halyard	39210	FDA UDI	Class II	Active
Halyard	42912	FDA UDI	Class II	Active
Med4 Elite	303839	FDA UDI	Class II	Active
Ballard* Closed Suction System for Adults	98295	FDA UDI	Class I	Active
Halyard	48401	FDA UDI	Class II	Active
Avanos	94815	FDA UDI	Class II	Active
Avanos	47954	FDA UDI	Class II	Active
Halyard	32758	FDA UDI	Class II	Active
Halyard	98667	FDA UDI	Class II	Active
Avanos	44950	FDA UDI	Class II	Active
Halyard	91472	FDA UDI	Class II	Unknown
Halyard	45823	FDA UDI	Class II	Active
Halyard	42865	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (57)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Avanos Medical, Inc. has 57 recall records spanning from October 8, 2019, to April 30, 2026, with statuses including completed, open, classified, and terminated. The recalls involve issues such as mechanical failures (e.g., cracked connectors, detached adaptors, blocked catheters), quality control concerns (e.g., incorrect expiration dates, missing instructions), and product distribution errors (e.g., missing components like air filters or incomplete labeling). Some recalls address supplier-related quality issues, while others pertain to device functionality or compliance with labeling requirements.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 30, 2026	Z-2347-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2335-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2344-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2333-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2337-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2348-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2341-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2334-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2352-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2338-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2342-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2350-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2349-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2340-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2343-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2339-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2345-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2336-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2346-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Apr 30, 2026	Z-2351-2026	—	open, classified	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Mar 19, 2025	Z-1525-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1522-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1527-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1521-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1524-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1526-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1528-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
Mar 19, 2025	Z-1523-2025	—	open, classified	Lack of sterility assurance for closed suction catheter systems
May 31, 2024	Z-2422-2024	—	open, classified	The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Mar 4, 2024	Z-2035-2024	—	open, classified	The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Mar 4, 2024	Z-2036-2024	—	open, classified	The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Mar 4, 2024	Z-2037-2024	—	open, classified	The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Jan 16, 2024	Z-1187-2024	—	open, classified	MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Jan 16, 2024	Z-1186-2024	—	open, classified	MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Oct 13, 2023	Z-0360-2024	—	open, classified	Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Aug 1, 2023	Z-2622-2023	—	completed	Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Apr 24, 2023	Z-1687-2023	—	terminated	Some of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023	Z-1684-2023	—	terminated	Some of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023	Z-1688-2023	—	terminated	Some of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023	Z-1686-2023	—	terminated	Some of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023	Z-1685-2023	—	terminated	Some of the ambIT kits were potentially distributed without an air in-line filter.
Feb 3, 2023	Z-1190-2023	—	terminated	Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Feb 3, 2023	Z-1189-2023	—	terminated	Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Feb 3, 2023	Z-1406-2023	—	terminated	Incorrect expiration date.
Sep 14, 2022	Z-0195-2023	—	terminated	Sterile extension sets were distributed without an expiration date
Mar 21, 2022	Z-1032-2022	—	terminated	Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
Dec 22, 2021	Z-0565-2022	—	terminated	The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Dec 22, 2021	Z-0566-2022	—	terminated	The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Nov 22, 2021	Z-0845-2022	—	terminated	Product was distributed with incorrect expiration date.
Nov 22, 2021	Z-0847-2022	—	terminated	Product was distributed with incorrect expiration date.
Nov 22, 2021	Z-0846-2022	—	terminated	Product was distributed with incorrect expiration date.
Oct 16, 2020	Z-0540-2021	—	terminated	Detachment of the Male AIV Adaptor from the Y-Connector.
Jul 29, 2020	Z-2969-2020	—	terminated	Devices had cracked or detached from the feeding tube body
Mar 16, 2020	Z-1822-2020	—	terminated	The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
Nov 5, 2019	Z-0788-2020	—	terminated	Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.
Oct 8, 2019	Z-0370-2020	—	terminated	The connector piece to the PEG tube does not pass over the guidewire.
Oct 8, 2019	Z-0371-2020	—	terminated	The connector piece to the PEG tube does not pass over the guidewire.