Alpharetta, GA, United States
Avanos Medical, Inc. recalls
19 recalls recorded since 2018, most recently on 30 April 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)6
Terminated or completed13
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2337-2026, Z-2343-2026, Z-2338-2026, Z-2348-2026, Z-2346-2026, Z-2334-2026, Z-2344-2026, Z-2335-2026, Z-2339-2026, Z-2352-2026, Z-2347-2026, Z-2349-2026 and 8 more
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
- Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
- Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
- and 12 more product lines
Ongoing Class I Medical devices
- Recall started
- 19 March 2025
- Reason
- Lack of sterility assurance for closed suction catheter systems
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1528-2025, Z-1521-2025, Z-1523-2025, Z-1525-2025, Z-1527-2025, Z-1526-2025, Z-1524-2025, Z-1522-2025
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Componen
- Brand 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: No
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Ongoing Class II Medical devices
- Recall started
- 31 May 2024
- Reason
- The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
- Distribution
- Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2422-2024
- MIC-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
Ongoing Class III Medical devices
- Recall started
- 4 March 2024
- Reason
- The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2037-2024, Z-2035-2024, Z-2036-2024
- NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c.
- NEOMED* 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.
- NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1m
Ongoing Class I Medical devices
- Recall started
- 16 January 2024
- Reason
- MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- Distribution
- Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1186-2024, Z-1187-2024
- MIC* 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 Feedi
- MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tu
Ongoing Class II Medical devices
- Recall started
- 13 October 2023
- Reason
- 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.
- Distribution
- US and South Africa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0360-2024
- AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Completed Class II Medical devices
- Recall started
- 1 August 2023
- Reason
- Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
- Distribution
- US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2622-2023
- COOLIEF 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 interf
Terminated Class II Medical devices
- Recall started
- 24 April 2023
- Terminated
- 2 August 2024
- Reason
- Some of the ambIT kits were potentially distributed without an air in-line filter.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1684-2023, Z-1686-2023, Z-1688-2023, Z-1687-2023, Z-1685-2023
- AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
- ambIT Cassette Filter Male Luer, Product Code: 220266
- SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
- AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Terminated Class I Medical devices
- Recall started
- 3 February 2023
- Terminated
- 5 September 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of Oklahoma.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1190-2023, Z-1189-2023
- BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
- BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Terminated Class II Medical devices
- Recall started
- 3 February 2023
- Terminated
- 19 August 2024
- Reason
- Incorrect expiration date.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1406-2023
- Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Terminated Class II Medical devices
- Recall started
- 14 September 2022
- Terminated
- 31 August 2023
- Reason
- Sterile extension sets were distributed without an expiration date
- Distribution
- US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0195-2023
- Y-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 EXTEN
Terminated Class I Medical devices
- Recall started
- 21 March 2022
- Terminated
- 9 September 2024
- Reason
- 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.
- Distribution
- Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1032-2022
- Avanos Cortrak 2 Enteral Access System (EAS)
Terminated Class II Medical devices
- Recall started
- 22 December 2021
- Terminated
- 15 August 2023
- Reason
- The External Retention Bolster contained in the kit may be a larger diameter than the tube.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Chile.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0566-2022, Z-0565-2022
- MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
- MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Terminated Class II Medical devices
- Recall started
- 22 November 2021
- Terminated
- 31 January 2023
- Reason
- Product was distributed with incorrect expiration date.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0846-2022, Z-0847-2022, Z-0845-2022
- BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
- BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
- BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Terminated Class II Medical devices
- Recall started
- 16 October 2020
- Terminated
- 30 September 2022
- Reason
- Detachment of the Male AIV Adaptor from the Y-Connector.
- Distribution
- Domestic distribution only: CA, CO, IL, LA, OH, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0540-2021
- CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Terminated Class II Medical devices
- Recall started
- 29 July 2020
- Terminated
- 31 January 2023
- Reason
- Devices had cracked or detached from the feeding tube body
- Distribution
- US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2969-2020
- AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Terminated Class II Medical devices
- Recall started
- 16 March 2020
- Terminated
- 31 August 2023
- Reason
- The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
- Distribution
- Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1822-2020
- CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Terminated Class II Medical devices
- Recall started
- 5 November 2019
- Terminated
- 16 August 2023
- Reason
- 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.
- Distribution
- Nationwide. Internationally distributed to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Honduras, India, Ireland, Israel, Italy, Korea, Republic of, Lebanon, Mexico, Nepal, Netherlands, New Zealand, Norway, Peru, Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0788-2020
- Haylard 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, El
Terminated Class II Medical devices
- Recall started
- 8 October 2019
- Terminated
- 16 March 2022
- Reason
- The connector piece to the PEG tube does not pass over the guidewire.
- Distribution
- Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0371-2020, Z-0370-2020
- CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
- CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.