Agency classClass IOur severity:Severe FDA (Devices)·Z-1524-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled for sterility assurance failure

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The recall affects 9,020 units 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 Class I. Per the rubric, FDA Class I recalls must not go below a score of 4, and lack of sterility assurance in a medical device poses risk of serious infection and harm requiring medical intervention.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction System for Adults, 14 F, T-Piece (Model 220135) closed suction catheters due to lack of sterility assurance. The affected lot/serial numbers are 1555453 and 1564227.

The recall affects 9,020 units that were distributed worldwide, including US nationwide distribution across multiple 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 in South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

Patients and healthcare providers who have received these catheters should contact Avanos Medical, Inc. for further guidance on the appropriate course of action. Healthcare facilities should verify whether they have received affected units and follow the manufacturer's instructions regarding use or return of the product.

The recalled product

Product: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Manufacturer: Avanos Medical, Inc.
Category: Medical Device — Closed Suction Catheter
Hazard: sterility-failure
infection-risk
Affected units: 9,020

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot Code: Lot/ Serial Number(s): 1555453
1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924

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 failure