The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1525-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled for lack of sterility assurance

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which by the rubric criterion requires a minimum score of 4. Lack of sterility assurance in medical devices used in direct patient contact (closed suction catheters) presents significant risk of serious health consequences including infection.

Plain-English summary

Avanos Medical, Inc. is recalling the Ballard Closed Suction System for Adults (Model 2210-5, 14 F, DSE) because of lack of sterility assurance for the closed suction catheter systems. The affected lot includes approximately 2,080 units with lot/serial number 1555424.

The products were distributed nationwide across the United States, including to the states of 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, and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

Healthcare providers and facilities that received these products should immediately verify that they are not using the affected lot. Any catheters matching lot number 1555424 should be removed from service. Healthcare providers should contact Avanos Medical, Inc. for guidance on product return or replacement procedures.

The recalled product

Product
Brand 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
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
2,080

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 →

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