Z-1724-2025Class II

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter

Name: Z-1724-2025 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-04-04
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-04-04 / Open, Classified / root cause: packaging

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter on 2025-04-04. FDA classified it as Class II and gives the reason as "Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1724-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-04
Posted: 2025-05-06
Recalling firm: Integra LifeSciences Corporation
Product: INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Product code: KTI Bronchoscope Accessory
Reason for recall: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the states of TX, MT, AL & OK.
Product codes and lots: Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1724-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1724-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-06

Product code KTI

K110218Class IIInspira Air Balloon Dilation SystemAcclarent, Inc. / cleared 2011-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)