Integra INSPIRA Airway Balloon Dilation System Recall: Incorrect Product Packaging
Integra LifeSciences recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK due to incorrect product packaging in carton. Affected units include specific model and lot numbers.
Lower-risk recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling the INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK airway balloon dilation catheter because it was packaged with the wrong product in the carton. This recall is important because using the incorrect product could lead to improper medical procedures. Read more at govinfonow.com/recall/52490-integra-inspira-airway-balloon-dilation-system-recall-incorrect-product-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/52490-integra-inspira-airway-balloon-dilation-system-recall-incorrect-product-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1724-2025
Cite this page
“Integra INSPIRA Airway Balloon Dilation System Recall: Incorrect Product Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52490-integra-inspira-airway-balloon-dilation-system-recall-incorrect-product-packaging. Based on FDA recall #Z-1724-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1724-2025%22&limit=1).
Why it’s dangerous
The recall states that the product was incorrectly packaged in the carton. This means the wrong item was included with the intended medical device, which could lead to using the incorrect product during procedures.
Who’s affected
Medical professionals who use the INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK for airway procedures are most at risk if they have the recalled product.
How to tell if you have this one
Check for model number BC1040AZ and lot number 240716A-PC on the carton. The product was sold with specific packaging details that indicate the incorrect item was included.
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check Product Packaging
Verify the model number BC1040AZ and lot number 240716A-PC on the carton to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide distribution in the states of TX, MT, AL & OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Montana, Oklahoma, Texas.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1724-2025 (April 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1724-2025 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.