Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

INSPIRA AIR BALLOON DILATION SYSTEM 10x40 Recalled by Integra LifeSciences Corp. (NeuroSciences) Due to Incorrect product packaged in INSPIRA AIR Balloon Dilation...

Date: April 4, 2025
Company: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. (NeuroSciences) directly.

Affected Products

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

Quantity: 6 units

Why Was This Recalled?

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integra LifeSciences Corp. (NeuroSciences)

Integra LifeSciences Corp. (NeuroSciences) has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report