Agency classClass IOur severity:Severe FDA (Devices)·Z-1526-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled due to sterility assurance failure

Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.

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. Per the rubric, FDA Class I recalls must not score below 4, and when paired with a medical device used in patient care (a closed suction catheter used in respiratory management) the Severe rating is appropriate.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 2271418-5 (Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI), due to lack of sterility assurance. A total of 1,420 units have been affected. The lot/serial number is 1555430 (UPC 00609038982632; DSP 10609038982639; Case 20609038982636).

The products were distributed worldwide with US nationwide distribution across 33 states including 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, and Wisconsin. International distribution includes South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

Patients or healthcare providers in possession of the recalled product should stop using it and contact Avanos Medical, Inc. for further instructions.

The recalled product

Product: Brand 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
Manufacturer: Avanos Medical, Inc.
Category: Medical Device — Respiratory / Suction System
Hazard: lack-of-sterility
infection-risk
Affected units: 1,420

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 →

Same manufacturer · Avanos Medical, Inc.

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Same hazard · lack of sterility