FDA recall record · openFDA

Integra LifeSciences Corp. (NeuroSciences)

30 FDA recalls on record (2025–2026) — 30 device. 30 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Packaging failures were identified which could lead to a breach in the sterile barrier. 8

Increased rate of out-of-specification endotoxin results. 5

Potential packaging failures, which could lead to a breach in the sterile barrier. 3

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. 3

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink 2

Recalls

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit. Class I 2025-04-11 CODMAN Disposable Perforator 11mm. Cranial Perforator. Class I 2025-09-26 Extended Tip Applicator, 15 CM, Box of 5. Class I 2025-05-22 Extended Tip Applicator, 8CM, Box of 5. Class I 2025-05-22 Extended Tip Applicator 8CM, Box of 1. Class I 2025-05-22 CODMAN Disposable Perforator, 14mm. Cranial perforator. Class I 2025-04-11 CODMAN Disposable Perforator 9mm. Cranial Perforator. Class I 2025-09-26 MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So Class I 2025-05-23 MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit Class II 2026-01-16 Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Class II 2026-03-19 Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc Class II 2026-01-16 Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Class II 2026-03-19 CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. Class II 2026-03-06 MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE Class II 2026-01-16 Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Class II 2026-03-19 Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Ca Class II 2026-04-10 Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Class II 2026-03-19 Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Class II 2026-03-19 Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di Class II 2025-12-12 Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa Class II 2025-08-05 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. Class II 2025-04-04 Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu Class II 2025-08-05 Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P Class II 2025-08-05 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 3162 Class II 2025-08-05 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDI Class II 2025-08-05 Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med Class II 2025-08-05 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Descr Class II 2025-08-05 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De Class II 2025-08-05 Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of t Class II 2025-12-12 TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev Class II 2025-10-03

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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