Integra LifeSciences Corp.
152 recalls on record · Latest: Mar 12, 2025
FDA Devices Moderate Mar 12, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): …
FDA Devices Moderate Feb 19, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Descripti…
FDA Devices Moderate Jan 29, 2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pre…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
FDA Devices Moderate Nov 6, 2024
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, includi…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, includi…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, includin…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, i…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
FDA Devices Moderate Nov 6, 2024
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
FDA Devices Moderate Nov 6, 2024
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including …
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
FDA Devices Moderate Nov 6, 2024
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including …
FDA Devices Moderate Nov 6, 2024
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including br…
FDA Devices Moderate Nov 6, 2024
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including br…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
FDA Devices Moderate Nov 6, 2024
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
FDA Devices Moderate Nov 6, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, includin…
FDA Devices Moderate Oct 16, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number …
FDA Devices Moderate Aug 14, 2024
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation Syst…
FDA Devices Moderate Jul 3, 2024
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and har…
FDA Devices Moderate May 29, 2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
FDA Devices Moderate Mar 6, 2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles o…
FDA Devices Moderate Mar 6, 2024
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Devices Moderate Mar 6, 2024
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Devices Moderate Mar 6, 2024
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Devices Moderate Mar 6, 2024
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Devices Moderate Mar 6, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
FDA Devices Moderate Dec 13, 2023
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catal…
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
FDA Devices Moderate Dec 13, 2023
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
FDA Devices Moderate Jan 18, 2023
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
FDA Devices Moderate Apr 20, 2022
Integra Universal Flexible Arm part number REF 1362275
FDA Devices Moderate Mar 30, 2022
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebros…
FDA Devices Moderate Dec 30, 2020
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system wh…
FDA Devices Moderate Dec 30, 2020
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CS…
FDA Devices Moderate Dec 16, 2020
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A20…
FDA Devices Moderate Sep 23, 2020
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. T…
FDA Devices Moderate Sep 23, 2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cut…
FDA Devices Moderate Sep 23, 2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn tre…
FDA Devices Low Mar 18, 2020
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral ner…
FDA Devices Moderate Dec 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Devices Moderate Dec 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Devices Moderate Dec 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Devices Moderate Dec 18, 2019