Avanos Medical, Inc. recalls
Every recall we track for Avanos Medical, Inc. — 57 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Avanos Medical, Inc. peaked in 2023 (10); 57 since 2017. 5% rated “stop using now”.
All FDA recall records for Avanos Medical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 2 | 0 | 1 | 3 |
| 2020 | 0 | 3 | 0 | 0 | 3 |
| 2021 | 0 | 0 | 5 | 0 | 5 |
| 2022 | 0 | 1 | 1 | 0 | 2 |
| 2023 | 2 | 0 | 6 | 2 | 10 |
| 2024 | 1 | 0 | 5 | 0 | 6 |
| 2025 | 0 | 0 | 8 | 0 | 8 |
| 2026 (to date) | 0 | 0 | 19 | 1 | 20 |
Most common reasons for Avanos Medical, Inc. recalls
What to do if you have a recalled Avanos Medical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Avanos Medical, Inc. recalls
19 shown- Lower riskMedical device
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Avanos Medical recalls CORFLO Safety PEG Kit with ENFit Connector (model 50-4320) due to lidocaine hydrochloride injection quality issues in sterile kits. Affected units include specific lot numbers and UDI-DI codes.
Avanos MedicalApr 30, 2026 - Lower riskMedical device
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A
Avanos Medical recalls Ballard Turbo-Cleaning Closed Suction Catheters (model 22714183-5) due to lack of sterility assurance. Affected units may pose infection risks if used improperly.
BallardMar 19, 2025 - Lower riskMedical device
Avanos Medical, Inc. recalls MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx
Recall of Avanos MIC-KEY Gastric-Jejunal Feeding Tube Kits with missing risk information in instructions. Affected models include non-ENFIT and ENFit connectors. No action required per official notice.
AvanosMay 31, 2024 - Lower riskMedical device
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange
Avanos Medical recalls nonsterile pharmacy syringes with missing expiry dates on shipping labels. These syringes could expire before use, posing a risk of ineffective medication delivery. Consumers should check product codes and lot numbers for affected items.
Avanos MedicalMar 4, 2024 - Lower riskMedical device
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector
Recalled Avanos Gastric-Jejunal Feeding Tube Kits with pre-filled syringes that may cause infection if used after being recalled by Nurse Assist.
AvanosJan 16, 2024 - Lower riskMedical device
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on
Avanos recalls specific lots of Ballard Closed Suction Systems for adults due to DEHP contamination in tubing. Affected units may pose health risks if used on patients. Contact Avanos for details.
AvanosOct 13, 2023 - UnratedMedical device
Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF
Avanos recalls COOLIEF RF Generators with F100/F101 faults. These devices may cause system errors. Stop using immediately to avoid potential issues.
AvanosAug 1, 2023 - Lower riskMedical device
Avanos Medical, Inc. recalls AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Avanos Medical recalls ambIT System kits (Product Code 220509) due to potential absence of air in-line filter. Affected kits have specific lot numbers from Dec 2023.
Avanos MedicalApr 24, 2023 - Lower riskMedical device
Avanos Medical, Inc. recalls Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Recall of Avanos Ballard Oral Care Swabs with incorrect expiration dates. Product codes 12241, 12243, 12251 affected. Check lot numbers for affected items.
AvanosFeb 3, 2023 - Stop using nowMedical device
Avanos Medical, Inc. recalls BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Avanos Medical recalls its Ballard Access Closed Suction System elbow manifold for neonates/pediatrics due to potential cracking during use, which could cause leaks and inadequate ventilation. Affected units include specific lot numbers from 2009.
Avanos MedicalFeb 3, 2023 - Lower riskMedical device
Avanos Medical, Inc. recalls Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as:
Avanos Medical recalls sterile extension sets for pain control pumps that lack an expiration date. This may lead to using expired medical tubing, potentially causing infections or complications.
Avanos MedicalSep 14, 2022 - Use cautionMedical device
Avanos Medical, Inc. recalls Avanos Cortrak 2 Enteral Access System (EAS)
Avanos recalls Cortrak 2 Enteral Access System devices with Anonymous Account Mode feature. Stop using immediately to confirm tube placement per hospital protocol.
AvanosMar 21, 2022 - Lower riskMedical device
Avanos Medical, Inc. recalls MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Avanos Medical recalls PEG kits with ENFit connectors due to potential mismatch between retention bolster and tube diameter. Affected kits include specific lot numbers from 2023.
AvanosDec 22, 2021 - Lower riskMedical device
Avanos Medical, Inc. recalls BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Avanos Medical recalls specific models of BALLAD Multi-Access Port Catheters due to incorrect expiration dates on some units. Affected products may have expired dates that could lead to improper use.
AvanosNov 22, 2021 - Use cautionMedical device
Avanos Medical, Inc. recalls CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Avanos Medical recalls pediatric neonatal feeding tubes with anti-IV connector due to risk of male AIV adaptor detaching from Y-connector. Affected units have specific product codes and lot numbers.
Avanos MedicalOct 16, 2020 - Use cautionMedical device
Avanos Medical, Inc. recalls AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Avanos Medical recalls specific models of gastrostomy feeding tubes due to risk of cracking or detachment from the tube body. Affected units include various sizes and lot numbers listed in the recall notice.
AvanosJul 29, 2020 - Use cautionMedical device
Avanos Medical, Inc. recalls CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Avanos recalls CORFLO PEG kits with specific product codes and lots due to potential tube blockage causing procedure delays or abortions. Affected users should check their kit details.
AvanosMar 16, 2020 - Use cautionMedical device
Avanos Medical, Inc. recalls Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code
Avanos Medical recalls Haylard Closed Suction Systems for neonates/pediatrics with potential blocked catheters that may cause inadequate suction and oxygen desaturation. Affected units include specific model numbers and lot codes from 2022-2024.
Avanos MedicalNov 5, 2019 - Use cautionMedical device
Avanos Medical, Inc. recalls CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per
Avanos Medical recalls 2 units of CORFLO PEG kits with ENFit connectors due to risk of guidewire not passing through the connector, potentially causing complications during medical procedures.
Avanos MedicalOct 8, 2019
Avanos Medical, Inc. recall questions
How many recalls has Avanos Medical, Inc. had?
57 recalls from Avanos Medical, Inc. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Avanos Medical, Inc. recall?
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320, dated Apr 30, 2026. Every Avanos Medical, Inc. recall is listed on this page, newest first.
Why are Avanos Medical, Inc. products recalled?
The most common reasons on record: Lack of sterility assurance for closed suction catheter systems (8); Product was distributed with incorrect expiration date. (3); The connector piece to the PEG tube does not pass over the guidewire. (2).
What should I do if I have a recalled Avanos Medical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Avanos Medical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.