Integra LifeSciences Corp. (NeuroSciences)

20 FDA enforcement actions

20 Total Recalls

8 Class I

12 Class II

0 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 12/12/2025 device

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 device

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 device

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 device

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 device

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 II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II: Risk 08/05/2025 device

Packaging failures were identified which could lead to a breach in the sterile barrier.
Class I: Dangerous 05/23/2025 device

Lack of sterility assurance.
Class I: Dangerous 05/22/2025 device

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I: Dangerous 05/22/2025 device

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I: Dangerous 05/22/2025 device

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I: Dangerous 04/11/2025 device

Inadequate weld that can potentially cause the product to disassemble.
Class I: Dangerous 04/11/2025 device

Inadequate weld that can potentially cause the product to disassemble.
Class II: Risk 04/04/2025 device

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

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.