CLASS I ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Ballard Closed Suction Catheters recalled by Avanos Medical
Avanos Medical is recalling Ballard Closed Suction Catheters, distributed nationwide in the US. The recall was initiated on 19 Mar 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1526-2025
- FDA event ID
- 96528
- Recalling firm
- Avanos Medical, Alpharetta, GA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 19 Mar 2025
- FDA classified
- 16 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 19 Mar 2025 | Recall initiated by company | |
| 16 Apr 2025 | Classified by FDA | +28 days |
| 23 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance for closed suction catheter systems
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraskaNew Jersey
Questions about this recall
Why was it recalled?
Lack of sterility assurance for closed suction catheter systems
Which lots are affected?
Lot Code: Lot/ Serial Number(s): 1555430 Each: 00609038982632 DSP: 10609038982639 Case: 20609038982636
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 96528This product is part of a recall event; the main page for the event is Ballard Closed Suction Catheters recalled by Avanos Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide | |
| CLASS I | Ballard Closed Suction Catheters recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide |
More recalls from Avanos Medical
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PULL recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | Corflo Safety PEG Kit with ENFit Connector recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |