Avanos Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1521-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No

Product Classification:

Class I

Date Initiated: March 19, 2025

Date Posted: April 23, 2025

Recall Number: Z-1521-2025

Event ID: 96528

Reason for Recall:

Lack of sterility assurance for closed suction catheter systems

Status: Ongoing

Product Quantity: 1980 units

Code Information:

Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 20609038938268

Distribution Pattern:

Worldwide - US Nationwide distribution including in 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, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.

Voluntary or Mandated:

Voluntary: Firm initiated