Recalls / —

—#213384

Product

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

FDA product code

KTI — Bronchoscope Accessory

Device class

Class 2

Medical specialty

Ear, Nose, Throat

510(k) numbers

K110218

Affected lot / code info

Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.

Why it was recalled

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Integra LifeSciences Corp. (NeuroSciences)

Address

1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern

US Nationwide distribution in the states of TX, MT, AL & OK.

Timeline

Recall initiated

2025-04-04

Posted by FDA

2025-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #213384. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.