Avanos Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1527-2025)

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: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A

Product Classification:

Class I

Date Initiated: March 19, 2025

Date Posted: April 23, 2025

Recall Number: Z-1527-2025

Event ID: 96528

Reason for Recall:

Lack of sterility assurance for closed suction catheter systems

Status: Ongoing

Product Quantity: 1040 units

Code Information:

Lot Code: Lot/ Serial Number(s): 1555468 Each: 00609038989655 DSP: 10609038989652 Case: 20609038989659

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