RecallRadar
FDA · Medical devicesClass I

Avanos Medical, Inc. medical device recall: Brand Name: Ballard Product Name: Closed Suction Catheters…

Sterility concerns

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96528
Recall initiated
Mar 19, 2025
Classified by FDA
Apr 16, 2025
Posted in Enforcement Report
Apr 23, 2025
Recalling firm
Avanos Medical, Inc.
Firm location
Alpharetta, GA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
Products in this event
8

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Lack of sterility assurance for closed suction catheter systems

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Mar 19, 2025. FDA classified it 28 days later, on Apr 16, 2025. This recall event covers 8 separate products, each with its own FDA recall number. Distribution reported by FDA: 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. Avanos Medical, Inc. has 19 recalls in our records.

Recalled products (8)

  • Z-1521-2025 Class I Ongoing

    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

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

    Quantity: 1980 units

  • Z-1522-2025 Class I Ongoing

    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

    Codes / lots: Lot Code: Lot/ Serial Number(s): 1561165 Each: 00609038938349 DSP: 10609038938346 Case: 20609038938343

    Quantity: 4000 units

  • Z-1523-2025 Class I Ongoing

    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

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

    Quantity: 9960 units

  • Z-1524-2025 Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

    Codes / lots: Lot Code: Lot/ Serial Number(s): 1555453, 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924

    Quantity: 9020 units

  • Z-1525-2025 Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A

    Codes / lots: Lot Code: Lot/ Serial Number(s): 1555424 Each: 00609038983103 DSP: 10609038983107 Case: 20609038983100

    Quantity: 2080 units

  • Z-1526-2025 Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A

    Codes / lots: Lot Code: Lot/ Serial Number(s): 1555430 Each: 00609038982632 DSP: 10609038982639 Case: 20609038982636

    Quantity: 1420 units

  • Z-1527-2025 Class I Ongoing

    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

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

    Quantity: 1040 units

  • Z-1528-2025 Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A

    Codes / lots: Lot Code: Lot/ Serial Number(s): 1555426 Each: 00609038982649 DSP: 10609038982646 Case: 20609038982643

    Quantity: 0

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96528
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.