INSPIRA AIR Balloon Dilation System (Integra LifeSciences) – Incorrect Product Packaging (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Brand
Integra LifeSciences Corp. (NeuroSciences)
Lot Codes / Batch Numbers
Model No. BC1040AZ, UDI: 20705031063157, Lot No. 240716A-PC.
Products Sold
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Integra LifeSciences Corp. (NeuroSciences) is recalling INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. due to Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Recommended Action
Per FDA guidance
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 FCA@integralife.com. 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 ACCUSCS@integralife.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026