Recall Z-1724-2025— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1724-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-04

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-04-04. It names one FDA 510(k) clearance: K110218. Product: INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.. Reason: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2025-04-04
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K110218 — INSPIRA AIR BALLOON DILATION SYSTEMAcclarent, Inc.·cleared 2011-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Data sourced from openFDA. This site is unofficial and independent of the FDA.