The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1522-2025·Announced 2025-04-23

Ballard Closed Suction Catheters recalled for lack of sterility assurance

Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed 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 recall of a medical device. Per the rubric, FDA Class I recalls must be scored at 4 (Severe) or higher. Although no reported illnesses or injuries are mentioned in the source, the classification itself and the nature of the hazard (lack of sterility assurance for a device in direct patient contact) justify a Severe rating.

Plain-English summary

Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 210, 10 F Elbow, used in neonatal and pediatric patients. The recall affects approximately 4,000 units distributed nationwide across multiple U.S. states and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.

The recalled product has been identified as lacking sterility assurance. Lot code 1561165 is affected, with UPC codes 00609038938349 (Each), 10609038938346 (DSP), and 20609038938343 (Case).

Patients, caregivers, and healthcare providers who have received or are using the recalled Ballard Closed Suction Catheters should contact Avanos Medical, Inc. immediately. Healthcare facilities should stop using affected units and return them to the manufacturer. The FDA has classified this as a Class I recall due to the risk associated with non-sterile medical devices intended for direct patient contact.

The recalled product

Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Respiratory / Suction Catheter
Hazard
Affected units
4,000

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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