FDA recall record · openFDA
Avanos Medical, Inc.
44 FDA recalls on record (2023–2026) — 44 device. 36 still ongoing.
12
Class I (most serious)
29
Class II
3
Class III
36
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits 20
Lack of sterility assurance for closed suction catheter systems 8
Some of the ambIT kits were potentially distributed without an air in-line filter. 5
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. 3
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. 2
Recalls
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Produc Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Pro Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Produc Class I 2025-03-19 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product D Class I 2025-03-19 MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec Class I 2024-01-16 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Class I 2024-01-16 BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. Class I 2023-02-03 BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. Class I 2023-02-03 Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Pr Class II 2026-04-30 Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catal Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24 Class II 2026-04-30 Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14 Class II 2026-04-30 Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 Class II 2026-04-30 Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog N Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catal Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catal Class II 2026-04-30 Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 Class II 2026-04-30 Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Pr Class II 2026-04-30 Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tu Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog N Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20 Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog N Class II 2026-04-30 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Pr Class II 2026-04-30 MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT Class II 2024-05-31 AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Class II 2023-04-24 SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Class II 2023-04-24 ambIT Cassette Filter Male Luer, Product Code: 220266 Class II 2023-04-24 SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Class II 2023-04-24 Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 Class II 2023-02-03 AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Class II 2023-04-24 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me Class II 2023-10-13 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha Class II 2023-08-01 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonS Class III 2024-03-04 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonS Class III 2024-03-04 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt Class III 2024-03-04
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.