Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall #Z-1724-2025 · 04/04/2025

Class II: Risk

Recall Details

Recall Number: Z-1724-2025
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Date Initiated: 04/04/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

Reason for Recall

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Product Description

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

Distribution Pattern

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

Other Recalls by Integra LifeSciences Corp. (NeuroSciences)

Class II: Risk 12/12/2025

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II: Risk 12/12/2025

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II: Risk 10/03/2025

It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

View all recalls by Integra LifeSciences Corp. (NeuroSciences) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.