Agency classClass IOur severity:Severe FDA (Devices)·Z-1528-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled for sterility assurance defect

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 22714183-5) due to lack of sterility assurance. The affected lot was distributed nationwide 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 as a Class I recall. Per the severity rubric, FDA Class I recalls that are not otherwise classified as Critical must be scored at 4 (Severe) or higher. Lack of sterility assurance on a medical device used for respiratory care poses risk of serious infection and qualifies as a Class I defect.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 22714183-5 (Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI), Lot/Serial Number 1555426. The recall is due to lack of sterility assurance for the closed suction catheter systems.

The affected lot was distributed nationwide to the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, as well as internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

Patients using the affected product should contact their healthcare provider. Healthcare facilities should quarantine and not use the affected lot and contact Avanos Medical, Inc. for instructions on product return and replacement.

The recalled product

Product: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 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 Care / Suction System
Hazard: sterility-assurance
infection-risk

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 · sterility assurance