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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.
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The recall feeds record what looks like the same company under more than one name:
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.
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 Operator s 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.
October 23, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressu
Hazard: There is a potential for a progressive decline in observed ICP readings of the monitor during use.
September 11, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding v
Hazard: A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
August 14, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during gene
Hazard: Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
May 29, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML
Hazard: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
May 29, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External C
Hazard: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
May 29, 2019Medical DevicesFDA
Integra LifeSciences Corp. recalls MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Pati
Hazard: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.