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All Recalls

Every Integra Lifesciences Corp. Recall

Sorted by most recent. Click any recall for full details.

146 recalls
High RiskFDA
Integra Lifesciences Corp.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catal...
Medical Devices·623 affected·Feb 6, 2025
High RiskFDA
Integra Lifesciences Corp.
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Produ...
Medical Devices·12,166 affected·Jan 10, 2025
High RiskFDA
Integra Lifesciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraven...
Medical Implants·132 affected·Dec 16, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·56,082 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tis...
Surgical Devices·2,056 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tis...
Surgical Devices·9,563 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tiss...
Surgical Devices·93,782 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection ...
Surgical Devices·69,179 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·33,478 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·21,553 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissu...
Surgical Devices·0 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue...
Surgical Devices·826 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·168,803 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue...
Surgical Devices·4,818 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, ...
Surgical Devices·1,222 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, ...
Surgical Devices·1,454 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·2,894 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissu...
Surgical Devices·3,494 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·80,515 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (M...
Medical Devices·120,124 affected·Sep 13, 2024
High RiskFDA
Integra Lifesciences Corp.
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Nav...
Surgical Devices·265 affected·Jul 9, 2024
High RiskFDA
Integra Lifesciences Corp.
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of ...
Surgical Devices·2 affected·May 29, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Medical Devices·1,822 affected·Apr 17, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ...
Medical Devices·1,324 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·27 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·161 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·30 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·188 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the br...
Medical Devices·4 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Medical Devices·59 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the b...
Medical Devices·1,639 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Medical Devices·160 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Medical Devices·510 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Surgical Devices·168 affected·Dec 2, 2022
High RiskFDA
Integra Lifesciences Corp.
Integra Universal Flexible Arm part number REF 1362275
Medical Devices·54 affected·Feb 28, 2022
High RiskFDA
Integra Lifesciences Corp.
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and...
Medical Devices·1,160 affected·Jan 21, 2022
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shu...
Surgical Devices·85 affected·Dec 14, 2020
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospin...
Surgical Devices·17 affected·Dec 14, 2020
High RiskFDA
Integra Lifesciences Corp.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures....
Surgical Devices·552 affected·Nov 11, 2020
High RiskFDA
Integra Lifesciences Corp.
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn ...
Medical Devices·13 affected·Aug 4, 2020
High RiskFDA
Integra Lifesciences Corp.
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 us...
Medical Devices·74 affected·Aug 4, 2020
High RiskFDA
Integra Lifesciences Corp.
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and...
Medical Devices·2 affected·Aug 4, 2020
RecallFDA
Integra Lifesciences Corp.
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of pe...
Medical Devices·55 affected·Feb 7, 2020
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·820 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·820 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·0 affected·Oct 21, 2019