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Avanos Medical, Inc. FDA Recalls
51 recalls on file across devices, 13 of them Class I and 35 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/CatalClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/CatalClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog NClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 PrClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog NClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding TuClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/CatalClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 PrClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog NClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 PrClass IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312Class IIApr 30, 2026Lidocaine hydrochloride injection, the subject of a supplier |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A ProducClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A ProClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A PrClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product DClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A ProductClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A ProducClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A ProductClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product DClass IMar 19, 2025Lack of sterility assurance for closed suction catheter syst |
| MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFITClass IIMay 31, 2024The IFU was missing some risk information requested by anoth |
| NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSClass IIIMar 4, 2024The expiration date was not printed on the outer shipping la |
| NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonStClass IIIMar 4, 2024The expiration date was not printed on the outer shipping la |
| NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSClass IIIMar 4, 2024The expiration date was not printed on the outer shipping la |
| MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit ConnecClass IJan 16, 2024MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile p |
| MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -Class IJan 16, 2024MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile p |
| AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on meClass IIOct 13, 2023Certain lots of BALLARD Closed Suction System for Adults, 14 |
| COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF chaClass IIAug 1, 2023Avanos has received an increase in complaints from customers |
| ambIT Cassette Filter Male Luer, Product Code: 220266Class IIApr 24, 2023Some of the ambIT kits were potentially distributed without |
| AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509Class IIApr 24, 2023Some of the ambIT kits were potentially distributed without |
| SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537Class IIApr 24, 2023Some of the ambIT kits were potentially distributed without |
| AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507Class IIApr 24, 2023Some of the ambIT kits were potentially distributed without |
| SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568Class IIApr 24, 2023Some of the ambIT kits were potentially distributed without |
| Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251Class IIFeb 3, 2023Incorrect expiration date. |
| BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.Class IFeb 3, 2023Potential for product manifold to crack during use on patien |
| BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.Class IFeb 3, 2023Potential for product manifold to crack during use on patien |
| Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SClass IISep 14, 2022Sterile extension sets were distributed without an expiratio |
| Avanos Cortrak 2 Enteral Access System (EAS)Class IMar 21, 2022Product labeling is being modified. STOP using the Anonymous |
| MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULLClass IIDec 22, 2021The External Retention Bolster contained in the kit may be a |
| MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULLClass IIDec 22, 2021The External Retention Bolster contained in the kit may be a |
| BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single UseClass IINov 22, 2021Product was distributed with incorrect expiration date. |
| BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single UseClass IINov 22, 2021Product was distributed with incorrect expiration date. |
| BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; SterilClass IINov 22, 2021Product was distributed with incorrect expiration date. |