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Integra LifeSciences Corp. (NeuroSciences) FDA Recalls
31 recalls on file across devices, 8 of them Class I and 31 still open. Matched by name to IART.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.Class IIJun 5, 2026The current Omni-Tract Surgical Retractor System IFU states |
| Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD CaClass IIApr 10, 2026Out-of-specification endotoxin result that did not meet the |
| Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.Class IIMar 19, 2026Increased rate of out-of-specification endotoxin results. |
| Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Class IIMar 19, 2026Increased rate of out-of-specification endotoxin results. |
| Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Class IIMar 19, 2026Increased rate of out-of-specification endotoxin results. |
| Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Class IIMar 19, 2026Increased rate of out-of-specification endotoxin results. |
| Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.Class IIMar 19, 2026Increased rate of out-of-specification endotoxin results. |
| CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.Class IIMar 6, 2026Software issue that renders the touch screen unresponsive. |
| MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing witClass IIJan 16, 2026Potential packaging failures, which could lead to a breach i |
| MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEClass IIJan 16, 2026Potential packaging failures, which could lead to a breach i |
| Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducClass IIJan 16, 2026Potential packaging failures, which could lead to a breach i |
| Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of tClass IIDec 12, 2025Potential corrosion stains on the surface of the 14-gauge Tu |
| Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when diClass IIDec 12, 2025Potential corrosion stains on the surface of the 14-gauge Tu |
| TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F RevClass IIOct 3, 2025It was determined that when the navigation system is configu |
| CODMAN Disposable Perforator 9mm. Cranial Perforator.Class ISep 26, 2025Expansion of recall of size 14 mm Codman Disposable Perforat |
| CODMAN Disposable Perforator 11mm. Cranial Perforator.Class ISep 26, 2025Expansion of recall of size 14 mm Codman Disposable Perforat |
| Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product DescrClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MedClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ PaClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: InfuClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162Class IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 PClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product DeClass IIAug 5, 2025Packaging failures were identified which could lead to a bre |
| MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow SoClass IMay 23, 2025Lack of sterility assurance. |
| Extended Tip Applicator, 15 CM, Box of 5.Class IMay 22, 2025Devices contain potentially out-of-specification levels of e |
| Extended Tip Applicator 8CM, Box of 1.Class IMay 22, 2025Devices contain potentially out-of-specification levels of e |
| Extended Tip Applicator, 8CM, Box of 5.Class IMay 22, 2025Devices contain potentially out-of-specification levels of e |
| CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.Class IApr 11, 2025Inadequate weld that can potentially cause the product to di |
| CODMAN Disposable Perforator, 14mm. Cranial perforator.Class IApr 11, 2025Inadequate weld that can potentially cause the product to di |
| INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.Class IIApr 4, 2025Incorrect product packaged in INSPIRA AIR Balloon Dilation S |