FDA Device Recall Z-1523-2025

Avanos Medical, Inc. · Alpharetta, GA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: Lot Code: Lot/ Serial Number(s): 1555215, 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315

Quantity: 9960 units

Reason for recall

Lack of sterility assurance for closed suction catheter systems

Recall record

Recall number: Z-1523-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
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.
Recall initiated: 2025-03-19
Classified by FDA Center: 2025-04-16
FDA published: 2025-04-23
Recalling firm: Avanos Medical, Inc.
Firm location: Alpharetta, GA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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