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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 2 of 125

Device	Model / Reference	Registries	Class	Status
Avanos	96881	FDA UDI	Class I	Active
Avanos	7120-12-1.2	FDA UDI	Class II	Active
PROBLOC* II Insulated Regional Block Needle	44924	FDA UDI	Class II	Active
Ballard* Closed Suction System	93829	FDA UDI	Class I	Active
Avanos	42740	FDA UDI	Class II	Active
Halyard	46646	FDA UDI	Class II	Active
Halyard	47186	FDA UDI	Class II	Active
Halyard	37296	FDA UDI	Class II	Unknown
Halyard	44918	FDA UDI	Class II	Active
Ballard* Manual Percussor	96867	FDA UDI	Class II	Active
Halyard	44116	FDA UDI	Class II	Active
Halyard	93882	FDA UDI	Class II	Unknown
Avanos	20-9228	FDA UDI	Class II	Active
Neomed*	BB-S12EO	FDA UDI	Class I	Active
Avanos	44081	FDA UDI	Class II	Active
Avanos	183109	FDA UDI	Class II	Active
Avanos	182A073	FDA UDI	Class II	Unknown
Halyard	13684	FDA UDI	Class II	Active
Avanos*	181A417	FDA UDI	Class II	Unknown
Avanos	13553	FDA UDI	Class II	Active
Halyard	35119	FDA UDI	Class II	Active
Halyard	94991	FDA UDI	Class II	Active
Avanos	B71011	FDA UDI	Class I	Unknown
Halyard	13625	FDA UDI	Class II	Active
Mic Peg Tube	9160-24	FDA UDI	Class II	Active
Game Ready	550500-93	FDA UDI	Class II	Active
Halyard	98572	FDA UDI	Class II	Unknown
Halyard	46939	FDA UDI	Class II	Active
RadiOpaque Radiofrequency Cannula	PMF18-54-10	FDA UDI	Class II	Active
Avanos	7143-12	FDA UDI	Class II	Active
Halyard	93288	FDA UDI	Class II	Unknown
ENFit SIL Feeding Tube	FTS5.0S-NC	FDA UDI	Class II	Active
Avanos	181A452	FDA UDI	Class II	Unknown
Ballard* Closed Suction System for Adults	93838	FDA UDI	Class I	Active
SiL Feeding Tube	FTM8.0S-EO	FDA UDI	Class II	Active
Halyard	47293	FDA UDI	Class II	Unknown
Avanos	45460	FDA UDI	Class II	Active
Corpgrip NG/NI tube retention system	25-010	FDA UDI	Class II	Active
Avanos	44157	FDA UDI	Class II	Active
Avanos	7140-16-4.5	FDA UDI	Class II	Active
Avanos	181263	FDA UDI	Class II	Unknown
Avanos	183A95	FDA UDI	Class II	Unknown
Halyard	42861	FDA UDI	Class II	Active
Halyard	42772	FDA UDI	Class II	Active
Avanos	94774	FDA UDI	Class II	Active
Ballard* Turbo-Cleaning Closed Suction System	98968	FDA UDI	Class I	Active
Ballard* Closed Suction System for Adults	22057	FDA UDI	Class I	Active
Avanos	94888	FDA UDI	Class II	Active
Avanos	13566	FDA UDI	Class II	Active
Halyard	42781	FDA UDI	Class II	Active

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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.