Recall archive
20 recalls · page 1 of 1
Reported Jun 17, 2026
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
Matched: Brand — Lack of sterility assurance for closed suction catheter systems
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Avanos Medical, Inc.
Matched: Brand — The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
Matched: Brand — MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2024
Avanos Medical, Inc. recalls Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits due to Potential Lack of Sterility Assurance
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Avanos Medical, Inc.
Matched: Brand · Product · Product details — Potential Lack of Sterility Assurance
FDA (recalls & safety alerts)
Reported Nov 29, 2023
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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);…
FDA (openFDA device enforcement)
Reported Sep 27, 2023
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Reason for recall — Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA (openFDA device enforcement)
Reported Jun 14, 2023
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — Some of the ambIT kits were potentially distributed without an air in-line filter.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Product · Product details — Incorrect expiration date.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
Matched: Brand — Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Product details — Sterile extension sets were distributed without an expiration date
FDA (openFDA device enforcement)
Reported May 25, 2022
Avanos Cortrak 2 Enteral Access System (EAS)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
Matched: Brand · Product · Product details — Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI…
FDA (openFDA device enforcement)
Reported Apr 6, 2022
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — Product was distributed with incorrect expiration date.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — The External Retention Bolster contained in the kit may be a larger diameter than the tube.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2020
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — Detachment of the Male AIV Adaptor from the Y-Connector.
FDA (openFDA device enforcement)
Reported Sep 23, 2020
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Product · Product details — Devices had cracked or detached from the feeding tube body
FDA (openFDA device enforcement)
Reported May 6, 2020
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
FDA (openFDA device enforcement)
Reported Jan 15, 2020
Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand · Reason for recall — Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or…
FDA (openFDA device enforcement)
Reported Nov 20, 2019
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
Matched: Brand — The connector piece to the PEG tube does not pass over the guidewire.
1 more product in this recall
FDA (openFDA device enforcement)
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