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Avanos Medical, Inc.

Avanos Medical, Inc. Recalls

All product recalls associated with Avanos Medical, Inc..

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Recall Summary

Total Recalls

24

Past Year

1

Class I (Serious)

0

Most Recent

Mar 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 24 recalls

Ballard Closed Suction Catheters (Avanos) – sterility concern (2025)

Lack of sterility assurance for closed suction catheter systems

FDAMar 19, 2025Nationwide• Avanos Medical, Inc.

MIC-KEY Feeding Tube Kit (Avanos) – Incomplete Risk Information (2024)

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

FDAMay 31, 2024Nationwide• Avanos Medical, Inc.

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

FDAMar 4, 2024Nationwide• Avanos Medical, Inc.

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MIC Gastric-Jejunal Feeding Tube (Avanos) – Syringe Recall (2024)

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

FDAJan 16, 2024Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: AVANOS BALLARD Closed Suction System for Adults, 14 Fr, D...

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.

FDAOct 13, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) G...

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

FDAAug 1, 2023AZ, CA, GA +13 more• Avanos Medical, Inc.

Avanos Medical, Inc.: ambIT Cassette Filter Male Luer, Product Code: 220266

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: SMMT ambIT Reusable Program - Luer Cass, Product Code: 22...

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 2...

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Some of the ambIT kits were potentially distributed without an air in-line filter.

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: BALLARD ACCESS Closed Suction System for Neonates/Pediatr...

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.

FDAFeb 3, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes...

Incorrect expiration date.

FDAFeb 3, 2023Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated C...

Sterile extension sets were distributed without an expiration date

FDASep 14, 2022CA, CO, FL +8 more• Avanos Medical, Inc.

Avanos Medical, Inc.: Avanos Cortrak 2 Enteral Access System (EAS)

Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

FDAMar 21, 2022Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-...

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

FDADec 22, 2021Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel ...

Product was distributed with incorrect expiration date.

FDANov 22, 2021Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbo...

Product was distributed with incorrect expiration date.

FDANov 22, 2021Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Ca...

Product was distributed with incorrect expiration date.

FDANov 22, 2021Nationwide• Avanos Medical, Inc.

Avanos Medical, Inc.: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV C...

Detachment of the Male AIV Adaptor from the Y-Connector.

FDAOct 16, 2020CA, CO, IL +3 more• Avanos Medical, Inc.