Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published March 19, 2025

Ballard Closed Suction Catheters Recall: Lack of Sterility Risk

Avanos Medical recalls Ballard Turbo-Cleaning Closed Suction Catheters (model 22714183-5) due to lack of sterility assurance. Affected units may pose infection risks if used improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1528-2025Medical deviceBallard ›
Take action

Contact the company

Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-4667
✎ GovInfoNow plain-language explainer

What happened, in plain English

Avanos Medical recalls Ballard Closed Suction Catheters (model 22714183-5) because they lack sterility assurance. Using these catheters without proper sterilization could lead to infections, especially in medical settings. Read more at govinfonow.com/recall/52594-ballard-closed-suction-catheters-recall-lack-of-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52594-ballard-closed-suction-catheters-recall-lack-of-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1528-2025

Cite this page

“Ballard Closed Suction Catheters Recall: Lack of Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52594-ballard-closed-suction-catheters-recall-lack-of-sterility-risk. Based on FDA recall #Z-1528-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2025%22&limit=1).

Why it’s dangerous

The catheters lack proper sterility assurance, meaning they may not be clean enough to prevent infections. If used without proper sterilization, this could lead to infections in patients, particularly in medical settings.

Who’s affected

Healthcare professionals and patients using the Ballard Turbo-Cleaning Closed Suction Catheters (model 22714183-5) may be affected. Those in medical facilities using these catheters for adult patients are at higher risk.

How to tell if you have this one

Check for the model number 22714183-5 on the Ballard Turbo-Cleaning Closed Suction Catheters. Units sold with lot numbers 1555426 or serial numbers 00609038982649 and 10609038982646 are affected.

  • Brand
    Ballard
  • Category
    Medical device
FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • 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 numberProduct, codes & lotsQuantity
Z-1521-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 206090389382681980 units
Z-1522-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1561165 Each: 00609038938349 DSP: 10609038938346 Case: 206090389383434000 units
Z-1523-2025Brand 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 Code: Lot/ Serial Number(s): 1555215, 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 206090389383159960 units
Z-1524-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1555453, 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 206090389449249020 units
Z-1525-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1555424 Each: 00609038983103 DSP: 10609038983107 Case: 206090389831002080 units
Z-1526-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1555430 Each: 00609038982632 DSP: 10609038982639 Case: 206090389826361420 units
Z-1527-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1555468 Each: 00609038989655 DSP: 10609038989652 Case: 206090389896591040 units
Z-1528-2025Brand 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; Lot Code: Lot/ Serial Number(s): 1555426 Each: 00609038982649 DSP: 10609038982646 Case: 206090389826430
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number 22714183-5 and lot/serial numbers on the catheters.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Mar 19, 202512. FDA classified it Class I: Apr 16, 202523. Published in FDA’s Enforcement Report: Apr 23, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1528-2025 (March 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1528-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA