The Recall Desk
SevereFDA (Devices)·Z-1521-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled for lack of sterility assurance

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 198, 8 F, Y-Adapter) for neonates and pediatrics due to lack of sterility assurance. The recall affects 1,980 units distributed nationwide and internationally.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I medical device recall. Per the severity rubric, FDA Class I recalls are never scored below 4, and given the critical nature of sterility assurance for invasive devices used in vulnerable neonatal and pediatric populations, a Severe rating is appropriate.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 198, 8 F, Y-Adapter, designed for use in neonates and pediatrics. The recall affects 1,980 units that were distributed worldwide, including throughout the United States and in Canada, Mexico, South Korea, New Zealand, Germany, England, Slovenia, France, Austria, and Guadalajara.

The recalled catheters lack sterility assurance. Lot Serial Number 1561168 is affected, with the following code identifiers: Each 00609038938264, DSP 10609038938261, and Case 20609038938268.

Patients or healthcare providers who have this product should stop using it and contact Avanos Medical, Inc. for instructions on return or replacement. Healthcare facilities should check their inventory for the affected lot and quarantine any units that match the recalled serial number.

The recalled product

Product
Brand 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
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Suction catheter
Hazard
Affected units
1,980

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Avanos Medical, Inc.

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Same hazard · sterility assurance

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