Is this your brand? Sign in to claim ownership.

Avanos Medical, Inc.

Last updated September 17, 2026

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 1 of 125

Device	Model / Reference	Registries	Class	Status
Halyard	95909	FDA UDI	Class II	Active
Avanos	40979	FDA UDI	Class II	Active
Halyard	46856	FDA UDI	Class II	Active
Avanos*	183A73	FDA UDI	Class II	Unknown
Avanos	181A446	FDA UDI	Class II	Unknown
Avanos	46933	FDA UDI	Class II	Active
Avanos	182214	FDA UDI	Class II	Unknown
Halyard	46784	FDA UDI	Class II	Unknown
Halyard	44288	FDA UDI	Class I	Active
ENFit Extension Set	EXT-30BNC	FDA UDI	Class II	Active
Ballard* Closed Suction System	98381	FDA UDI	Class I	Active
Halyard	45996	FDA UDI	Class II	Active
Halyard	92984	FDA UDI	Class II	Unknown
Avanos	01-EC-200-2205	FDA UDI	Class I	Active
Halyard	94881	FDA UDI	Class II	Active
MIC* Gastric - Jejunal Feeding Tube Kit	0260-22	FDA UDI	Class II	Active
Neomed*	UK	FDA UDI	Class II	Active
Halyard	48567	FDA UDI	Class II	Active
Avanos	18338	FDA UDI	Class II	Unknown
Avanos	94804	FDA UDI	Class II	Active
Reusable ENFit Syringe	NEO12	FDA UDI	Class II	Active
Avanos	42-9558	FDA UDI	Class II	Active
Avanos	47049	FDA UDI	Class II	Active
Halyard	94901	FDA UDI	Class II	Active
Halyard	46905	FDA UDI	Class II	Active
Halyard	44945	FDA UDI	Class II	Active
Avanos	92418	FDA UDI	Class II	Unknown
Halyard	11023	FDA UDI	Class II	Active
Halyard	42827	FDA UDI	Class II	Active
Avanos	44068	FDA UDI	Class II	Active
Avanos	42-7361	FDA UDI	Class II	Active
Avanos	7140-18-6.0	FDA UDI	Class II	Active
Avanos	46223	FDA UDI	Class II	Active
Game Ready Med4 Accessory Kit	303945-EN06	FDA UDI	Class II	Active
Halyard	90901	FDA UDI	Class II	Active
Halyard	32772	FDA UDI	Class II	Active
Halyard	45162	FDA UDI	Class II	Active
Halyard	12487	FDA UDI	Class II	Active
Avanos*	183A25	FDA UDI	Class II	Unknown
Avanos	182A258	FDA UDI	Class II	Unknown
Avanos	181A356	FDA UDI	Class II	Unknown
Halyard	47072	FDA UDI	Class II	Active
Halyard	45428	FDA UDI	Class II	Active
Avanos	39240	FDA UDI	Class II	Active
Halyard	44097	FDA UDI	Class II	Active
Ballard* Closed Suction System for Adults	94492	FDA UDI	Class I	Active
Avanos	95843	FDA UDI	Class II	Active
Avanos	44280	FDA UDI	Class II	Active
Avanos	44573	FDA UDI	Class II	Active
Halyard	99899	FDA UDI	Class II	Unknown

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.

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.