Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

Agency Publication Date: April 16, 2025

Summary

Avanos Medical, Inc. has recalled approximately 29,500 units of Ballard brand Closed Suction Catheters because they may not be sterile. The recall involves multiple models designed for use with neonates, pediatric patients, and adults, including systems with various adapters and turbo-cleaning features. No injuries or medical incidents have been reported to date regarding this issue.

Risk

Devices that lack sterility assurance can introduce bacteria or other harmful pathogens directly into a patient's respiratory system. This poses a significant risk of serious infection or other medical complications for patients requiring suction assistance.

What You Should Do

This recall affects Ballard brand Closed Suction Catheters, including systems designed for neonates, children, and adults with catalog numbers 198, 210, 20083, 220135, 2210-5, 2271418-5, 227-5, and 22714183-5.
Check your product labels for the catalog number and the lot number to determine if your device is part of the recall. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately and quarantine any remaining inventory to prevent further use.
Contact Avanos Medical, Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information or questions about this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter

Model / REF:

198

Lot Numbers:

1561168

GTIN:

00609038938264

10609038938261

20609038938268

Quantity: 1980 units

Product: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow

Model / REF:

210

Lot Numbers:

1561165

GTIN:

00609038938349

10609038938346

20609038938343

Quantity: 4000 units

Product: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow

Model / REF:

20083

Lot Numbers:

1555215

1555217

GTIN:

00609038938311

10609038938318

20609038938315

Quantity: 9960 units

Product: Ballard Closed Suction System for Adults, 14 F, T-Piece

Model / REF:

220135

Lot Numbers:

1555453

1564227

GTIN:

00609038944920

10609038944927

20609038944924

Quantity: 9020 units

Product: Ballard Closed Suction System for Adults, 14 F, DSE

Model / REF:

2210-5

Lot Numbers:

1555424

GTIN:

00609038983103

10609038983107

20609038983100

Quantity: 2080 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI

Model / REF:

2271418-5

Lot Numbers:

1555430

GTIN:

00609038982632

10609038982639

20609038982636

Quantity: 1420 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE

Model / REF:

227-5

Lot Numbers:

1555468

GTIN:

00609038989655

10609038989652

20609038989659

Quantity: 1040 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Model 22714183-5)

Model / REF:

22714183-5

Lot Numbers:

1555426

GTIN:

00609038982649

10609038982646

20609038982643

Quantity: 0 units distributed for this specific lot

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96528

Status: Active

Manufacturer: Avanos Medical, Inc.

Sold By: Authorized Medical Distributors; Healthcare Facilities

Manufactured In: United States

Units Affected: 8 products (1980 units; 4000 units; 9960 units; 9020 units; 2080 units; 1420 units; 1040 units; 0)

Distributed To: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Ballard brand Closed Suction Catheters, including systems designed for neonates, children, and adults with catalog numbers 198, 210, 20083, 220135, 2210-5, 2271418-5, 227-5, and 22714183-5.

Check your product labels for the catalog number and the lot number to determine if your device is part of the recall. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately and quarantine any remaining inventory to prevent further use.

Contact Avanos Medical, Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information or questions about this recall.

Affected Products

Product: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter

Model / REF:

198

Lot Numbers:

1561168

GTIN:

00609038938264

10609038938261

20609038938268

Quantity: 1980 units

Product: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow

Model / REF:

210

Lot Numbers:

1561165

GTIN:

00609038938349

10609038938346

20609038938343

Quantity: 4000 units

Product: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow

Model / REF:

20083

Lot Numbers:

1555215

1555217

GTIN:

00609038938311

10609038938318

20609038938315

Quantity: 9960 units

Product: Ballard Closed Suction System for Adults, 14 F, T-Piece

Model / REF:

220135

Lot Numbers:

1555453

1564227

GTIN:

00609038944920

10609038944927

20609038944924

Quantity: 9020 units

Product: Ballard Closed Suction System for Adults, 14 F, DSE

Model / REF:

2210-5

Lot Numbers:

1555424

GTIN:

00609038983103

10609038983107

20609038983100

Quantity: 2080 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI

Model / REF:

2271418-5

Lot Numbers:

1555430

GTIN:

00609038982632

10609038982639

20609038982636

Quantity: 1420 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE

Model / REF:

227-5

Lot Numbers:

1555468

GTIN:

00609038989655

10609038989652

20609038989659

Quantity: 1040 units

Product: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Model 22714183-5)

Model / REF:

22714183-5

Lot Numbers:

1555426

GTIN:

00609038982649

10609038982646

20609038982643

Quantity: 0 units distributed for this specific lot

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96528

Status: Active

Manufacturer: Avanos Medical, Inc.

Sold By: Authorized Medical Distributors; Healthcare Facilities

Manufactured In: United States

Units Affected: 8 products (1980 units; 4000 units; 9960 units; 9020 units; 2080 units; 1420 units; 1040 units; 0)