Integra LifeSciences Corp. (NeuroSciences)

FDA Regulatory Profile

Integra LifeSciences Corp. (NeuroSciences) appears in FDA public data with 31 recalls — including 8 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2714-2026, Class II) was initiated on Jun 5, 2026.

Summary

Total Recalls
31 (8 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2714-2026Class IIOmniTract Surgical Retractor System, which includes 633 of the firm s product codes.Jun 5, 2026
Z-2173-2026Class IICodman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. TApr 10, 2026
Z-1819-2026Class IICytal Burn Matrix 7x10 cm. Product ID: BMM0710.Mar 19, 2026
Z-1820-2026Class IICytal Burn Matrix 10x15 cm. Product ID: BMM1015.Mar 19, 2026
Z-1816-2026Class IICytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Mar 19, 2026
Z-1817-2026Class IICytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Mar 19, 2026
Z-1818-2026Class IICytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Mar 19, 2026
Z-1828-2026Class IICUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.Mar 6, 2026
Z-1365-2026Class IIPrivate Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which haJan 16, 2026
Z-1363-2026Class IIMediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoJan 16, 2026
Z-1364-2026Class IIMEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) Jan 16, 2026
Z-1036-2026Class IICodman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit Dec 12, 2025
Z-1037-2026Class IICodman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor BasDec 12, 2025
Z-0420-2026Class IITruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog NumbeOct 3, 2025
Z-0374-2026Class ICODMAN Disposable Perforator 9mm. Cranial Perforator.Sep 26, 2025
Z-0373-2026Class ICODMAN Disposable Perforator 11mm. Cranial Perforator.Sep 26, 2025
Z-2505-2025Class IIBrand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product DescriAug 5, 2025
Z-2506-2025Class IIBrand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 ProdAug 5, 2025
Z-2507-2025Class IIBrand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/CatalogAug 5, 2025
Z-2511-2025Class IIBrand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: Aug 5, 2025