Integra LifeSciences Corp. (NeuroSciences) Recalls

28 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (28)

March 19, 2026
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Increased rate of out-of-specification endotoxin results.
Class II
March 19, 2026
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
Class II
March 19, 2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Increased rate of out-of-specification endotoxin results.
Class II
March 19, 2026
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Increased rate of out-of-specification endotoxin results.
Class II
March 19, 2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
Class II
January 16, 2026
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound heal
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class II
January 16, 2026
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids aut
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class II
January 16, 2026
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class II
December 12, 2025
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II
December 12, 2025
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural a
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II
October 3, 2025
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
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 II
September 26, 2025
CODMAN Disposable Perforator 9mm. Cranial Perforator.
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
September 26, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
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
August 5, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a m
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM H
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Ac
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist w
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Lepto
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
August 5, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptosperm
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class II
May 23, 2025
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Lack of sterility assurance.
Class I
May 22, 2025
Extended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
May 22, 2025
Extended Tip Applicator, 8CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
May 22, 2025
Extended Tip Applicator 8CM, Box of 1.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
April 11, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Inadequate weld that can potentially cause the product to disassemble.
Class I
April 11, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
Class I
April 4, 2025
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Class II

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