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Integra LifeSciences Corp. (NeuroSciences) Recalls

31 recalls on record · May 14, 2025 to July 15, 2026 · Medical Devices

Recalls by year

25
26

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

July 15, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Hazard: The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
May 20, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Ca
Hazard: Out-of-specification endotoxin result that did not meet the acceptance criteria.
April 29, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Hazard: Software issue that renders the touch screen unresponsive.
April 22, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Hazard: Increased rate of out-of-specification endotoxin results.
April 22, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Hazard: Increased rate of out-of-specification endotoxin results.
April 22, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Hazard: Increased rate of out-of-specification endotoxin results.
April 22, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Hazard: Increased rate of out-of-specification endotoxin results.
April 22, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Hazard: Increased rate of out-of-specification endotoxin results.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
January 14, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of t
Hazard: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
January 14, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di
Hazard: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
November 12, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev
Hazard: 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.
November 12, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator 9mm. Cranial Perforator.
Hazard: 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.
November 12, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator 11mm. Cranial Perforator.
Hazard: 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.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Descr
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDI
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
September 10, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa
Hazard: Packaging failures were identified which could lead to a breach in the sterile barrier.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So
Hazard: Lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM, Box of 1.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator, 15 CM, Box of 5.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator, 8CM, Box of 5.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
May 14, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Hazard: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
May 14, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Hazard: Inadequate weld that can potentially cause the product to disassemble.