Avanos Medical recalls
14 official recalls and safety alerts involving Avanos Medical since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Avanos Medical or the relevant agency.
- 2026-06-17
USAvanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- 2025-04-23
- US
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description:…
Lack of sterility assurance for closed suction catheter systems
FDA · DeviceAvanos Medical, Inc.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2024-07-31
- US
Avanos Medical, Inc. recalls MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY*…
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide - There was also government and…Official notice → - 2024-06-19
- US
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code…
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Australia, New…Official notice → - 2024-03-13
- US
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector -…
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - 2023-11-29
- US
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
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…
- 2023-09-27
- US
Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be…
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA · DeviceAvanos Medical, Inc.US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH,…Official notice → - 2023-06-14
- US
Avanos Medical, Inc. recalls AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Some of the ambIT kits were potentially distributed without an air in-line filter.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Texas and…Official notice → - 2023-04-26
- US
Avanos Medical, Inc. recalls Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Incorrect expiration date.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice → - 2023-03-22
- US
Avanos Medical, Inc. recalls BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
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.
FDA · DeviceAvanos Medical, Inc.US Nationwide distribution in the state of Oklahoma.Official notice → - 2022-11-16
- US
Avanos Medical, Inc. recalls Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL…
Sterile extension sets were distributed without an expiration date
- 2022-05-25
- US
Avanos Medical, Inc. recalls Avanos Cortrak 2 Enteral Access System (EAS)
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.
FDA · DeviceAvanos Medical, Inc.Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany,…Official notice → - 2022-04-06
- US
Avanos Medical, Inc. recalls BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Product was distributed with incorrect expiration date.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Oklahoma…Official notice → - 2022-02-16
- US
Avanos Medical, Inc. recalls MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada and Chile.Official notice →