The Recall Desk

Manufacturer

Integra LifeSciences Corp.

217 recalls in our database name Integra LifeSciences Corp. as the manufacturing or recalling firm.

What the numbers show

Total
217
Critical
0
Severe
8
Most recent
2025-03-12

Of the 217 recalls from Integra LifeSciences Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 217

  • ModerateFDA (Devices)·Z-0631-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0648-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Sterilization Tray

    Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0649-2020·2019-12-18

    Integra CUSA Clarity System Recall for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0651-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recall for Drying Time Discrepancy

    Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0617-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0622-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity systems because the 36 kHz sterilization tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0625-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0650-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity system because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0614-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Drying Time Discrepancy

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0633-2020·2019-12-18

    Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0642-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0636-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0641-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0124-2020·2019-10-23

    Integra LifeSciences Recalls Cerelink ICP Monitor Due to Reading Decline

    Integra LifeSciences is recalling 189 Cerelink ICP Monitor units because they may show a progressive decline in intracranial pressure readings during use.

    Product
    Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2435-2019·2019-09-11

    Integra Jarit GEMINI CLAMP Recalled Due to Potential Instrument Breakage

    Integra LifeSciences Corp. is recalling 237 units of the Jarit GEMINI CLAMP because a small crack may cause corrosion and breakage after repeated sterilization.

    Product
    Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2019·2019-08-14

    Integra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect

    Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.

    Product
    Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1312-2019·2019-05-29

    Integra LifeSciences Recalls LimiTorr and MoniTorr Stopcock Components

    Integra LifeSciences is recalling LimiTorr and MoniTorr stopcock components due to a complaint trend regarding breakage.

    Product
    LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2019·2019-05-29

    Integra MoniTorr CSF Drainage System Recalled for Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems due to a complaint trend regarding stopcock breakage.

    Product
    MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2019·2019-05-29

    Integra LifeSciences Recalls MoniTorr CSF Drainage Systems Due to Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems because the LimiTorr Transducer Mount and MoniTorr Panel Mount stopcocks may break.

    Product
    MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Str
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1162-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling 2,029 Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1152-2019·2019-04-24

    Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error

    Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.

    Product
    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1160-2019·2019-04-24

    Integra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Errors

    Integra LifeSciences is recalling Tibial Total Ankle Prosthesis Trays due to incorrect metallic coating symbols on labels and instructions.

    Product
    Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1172-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1151-2019·2019-04-24

    Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error

    Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
    Category
    Medical Device
    Distribution
    26 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Integra LifeSciences

company in Plainsboro Center, United States

Country
United States
Founded
1989

Official website

Source: Wikidata (Q30283982), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.