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Integra LifeSciences Recalls
246 recalls on record · June 20, 2012 to March 12, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 20, 2022Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Hazard: Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
March 30, 2022Medical DevicesFDA
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moni
Hazard: Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
March 30, 2022Medical DevicesFDA
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moni
Hazard: Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
August 18, 2021Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Numb
Hazard: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
April 14, 2021Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking.
Hazard: Incorrect labeling, Catheter did not have the required holes and markings
December 30, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shu
Hazard: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
December 30, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a c
Hazard: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
December 16, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosur
Hazard: Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
September 23, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in pl
Hazard: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
September 23, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic sur
Hazard: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
September 23, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: ar
Hazard: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
March 18, 2020Medical DevicesFDA
Integra LifeSciences Corp. recalls NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for
Hazard: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
December 18, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Hazard: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.