INSPIRA AIR recallZ-1724-2025 · Integra LifeSciences Corp. (NeuroSciences) · initiated Apr 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
FDA root cause category: Under Investigation by firm
What the company is doing
A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" dated 4/4/25 was mailed to consignees. The notice instructs consignees to inspect their inventory for affected devices and immediately quarantine any identified units. Consignees are asked to forward the notice to users in their facility of the device being recalled and to maintain a copy of the notice for their records. The provided Acknowledgement Form is to be completed and returned to Integra via FAX at 1-609-750-4220 or by email to [email protected]. RMA numbers will be provided to consignees upon receipt of the Acknowledgement Form by Integra. Consignees with any questions can call Acclarent Customer Service Monday through Friday from 6:30 AM PST to 4:30 PM PST at 1-877-755-2789 or by email at [email protected].
Recall details
- Recall number
- Z-1724-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 4, 2025
- Posted by the FDA
- May 6, 2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 6 units
- Product code
- KTI
- FDA submissions
- K110218
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
Product description
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Code information (models, lots, serial numbers)
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INSPIRA AIR BC1040AZAcclarent, Inc. · BRONCHOSCOPE ACCESSORY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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