Avanos Medical, Inc.
24 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Avanos Medical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-23FDA-DeviceClass IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
Lack of sterility assurance for closed suction catheter systems
- 2024-07-31FDA-DeviceClass IIMIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18-
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
- 2024-06-19FDA-DeviceClass IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orang
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- 2024-06-19FDA-DeviceClass IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile,
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- 2024-06-19FDA-DeviceClass IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonS
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- 2024-03-13FDA-DeviceClass IMIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- 2024-03-13FDA-DeviceClass IMIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit wit
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- 2023-11-29FDA-DeviceClass IIAVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
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); however, Avanos has determined that the tubing components of the product did contain DEHP.
- 2023-09-27FDA-DeviceClass IICOOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
- 2023-06-14FDA-DeviceClass IIambIT Cassette Filter Male Luer, Product Code: 220266
Some of the ambIT kits were potentially distributed without an air in-line filter.
- 2023-06-14FDA-DeviceClass IISMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Some of the ambIT kits were potentially distributed without an air in-line filter.
- 2023-06-14FDA-DeviceClass IISMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Some of the ambIT kits were potentially distributed without an air in-line filter.
- 2023-06-14FDA-DeviceClass IIAVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Some of the ambIT kits were potentially distributed without an air in-line filter.
- 2023-06-14FDA-DeviceClass IIAVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Some of the ambIT kits were potentially distributed without an air in-line filter.
- 2023-04-26FDA-DeviceClass IIAvanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Incorrect expiration date.
- 2023-03-22FDA-DeviceClass IBALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
- 2023-03-22FDA-DeviceClass IBALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Get notified about new Avanos Medical, Inc. recalls
Free weekly digest. We email when a new federal recall affects Avanos Medical, Inc. or anything else in your household.
Get the Sunday Brief