The Recall Desk
SevereFDA (Devices)·Z-1527-2025·Announced 2025-04-23

Ballard Closed Suction Catheters lack sterility assurance

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 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 classified this as a Class I recall. Per the severity rubric, FDA Class I recalls are never scored below 4, and this medical device recall involves loss of sterility assurance for a catheter—a direct-contact invasive device—which creates significant potential for infection.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Turbo-Cleaning Closed Suction System for Adults (Model 227-5, 14 F, DSE) due to a lack of sterility assurance. The recalled product includes 1,040 units identified by Lot/Serial Number 1555468.

The closed suction catheters were distributed worldwide, including throughout the United States (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, WI) and internationally (South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara).

Patients and healthcare providers who have this product should contact Avanos Medical, Inc. for instructions on return or replacement. This is a Class I recall, indicating a serious health hazard.

The recalled product

Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Closed Suction Catheter
Hazard
Affected units
1,040

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 failure

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