Avanos Medical, Inc.
Complete recall history across all FDA and CPSC categories — 37 total recalls
Avanos Medical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (37)
FDA medical device enforcement actions by Avanos Medical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I |
| May 31, 2024 | MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement,... | The IFU was missing some risk information requested by another country to be ... | Class II |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to e... | Class III |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to e... | Class III |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to e... | Class III |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe... | Class I |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe... | Class I |
| Oct 13, 2023 | AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... | Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI wer... | Class II |
| Aug 1, 2023 | COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four i... | Avanos has received an increase in complaints from customers for COOLIEF RF G... | Class II |
| Apr 24, 2023 | AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 | Some of the ambIT kits were potentially distributed without an air in-line fi... | Class II |
| Apr 24, 2023 | SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 | Some of the ambIT kits were potentially distributed without an air in-line fi... | Class II |
| Apr 24, 2023 | ambIT Cassette Filter Male Luer, Product Code: 220266 | Some of the ambIT kits were potentially distributed without an air in-line fi... | Class II |
| Apr 24, 2023 | SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 | Some of the ambIT kits were potentially distributed without an air in-line fi... | Class II |
| Apr 24, 2023 | 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 fi... | Class II |
| Feb 3, 2023 | Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 1224... | Incorrect expiration date. | Class II |
| Feb 3, 2023 | BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. | Potential for product manifold to crack during use on patients, possibly caus... | Class I |
| Feb 3, 2023 | BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. | Potential for product manifold to crack during use on patients, possibly caus... | Class I |
| Sep 14, 2022 | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... | Sterile extension sets were distributed without an expiration date | Class II |
| Mar 21, 2022 | Avanos Cortrak 2 Enteral Access System (EAS) | Product labeling is being modified. STOP using the Anonymous Account Mode fea... | Class I |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | The External Retention Bolster contained in the kit may be a larger diameter ... | Class II |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 F... | The External Retention Bolster contained in the kit may be a larger diameter ... | Class II |
| Nov 22, 2021 | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement f... | Product was distributed with incorrect expiration date. | Class II |
| Nov 22, 2021 | BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French;... | Product was distributed with incorrect expiration date. | Class II |
| Nov 22, 2021 | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... | Product was distributed with incorrect expiration date. | Class II |
| Oct 16, 2020 | CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector | Detachment of the Male AIV Adaptor from the Y-Connector. | Class II |
| Jul 29, 2020 | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Devices had cracked or detached from the feeding tube body | Class II |
| Mar 16, 2020 | CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit | The CORFLO PEG tube may become blocked at the center of the adapter (occluded... | Class II |
| Nov 5, 2019 | Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-... | Avanos Medical has received reports stating that the central lumen of some 5 ... | Class II |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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