The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1523-2025·Announced 2025-04-23

Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.

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: This is an FDA Class I medical device recall. Class I recalls, per the severity rubric, are assigned a minimum score of 4 (Severe), indicating serious risk of harm to health or safety.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Model 20083) due to lack of sterility assurance. Approximately 9,960 units have been distributed worldwide, including throughout the United States and internationally to countries including South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

The affected lot numbers are 1555215 and 1555217. Affected customers should immediately stop using these devices and contact Avanos Medical, Inc. for instructions on return and replacement. Healthcare providers and patients should report any adverse events to the FDA.

For more information, customers can reference the FDA recall number Z-1523-2025.

The recalled product

Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Respiratory / Suction Systems
Hazard
Affected units
9,960

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): 1555215
  • 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315

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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