CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
Inspira Air Balloon Dilation System Airway balloon dilation catheter recalled
Integra LifeSciences Corp. (NeuroSciences) is recalling Inspira Air Balloon Dilation System Airway balloon dilation catheter, distributed nationwide in the US. The recall was initiated on 4 Apr 2025 and the FDA has classified it as Class II.
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-1724-2025
- FDA event ID
- 96672
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Apr 2025
- FDA classified
- 6 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 4 Apr 2025 | Recall initiated by company | |
| 6 May 2025 | Classified by FDA | +32 days |
| 14 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Where it was distributed
US Nationwide distribution in the states of TX, MT, AL & OK.
Questions about this recall
Why was it recalled?
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Which lots are affected?
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Where was it sold?
US Nationwide distribution in the states of TX, MT, AL & OK.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Integra LifeSciences Corp. (NeuroSciences)
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|---|---|---|---|---|---|
| Device | CLASS II | OmniTract Surgical Retractor System recalled | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
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| Device | CLASS II | CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | 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 |