FDA Medical devices recall ·
Ballard Product Name: Closed Suction Catheters Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1521-2025
- Date
- (initiated March 19, 2025)
- Company / brand
- Avanos Medical, Inc.
5405 Windward Pkwy, Alpharetta, GA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1980 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of sterility assurance for closed suction catheter systems
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 20609038938268
Distribution
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.
States: Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1521-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.