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.

176–200 of 217

  • ModerateFDA (Devices)·Z-1618-2015·2015-05-27

    Integra Recalls Camino ICP Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.

    Product
    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1619-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1620-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speaker malfunctions.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1452-2015·2015-04-22

    Integra Flowable Wound Matrix Recalled for Stability Criteria Failures

    Integra LifeSciences is recalling 287 packages of Flowable Wound Matrix because the product failed stability acceptance criteria for visual appearance and force vs. displacement.

    Product
    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0813-2015·2014-12-24

    Integra LifeSciences Recalls Non-Radiopaque PyroSphere CMC and TMT Implants

    Integra LifeSciences is recalling 19 units of PyroSphere CMC and TMT implants because they are non-radiopaque, potentially limiting post-surgical imaging.

    Product
    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0831-2015·2014-12-24

    Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values

    Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2015·2014-12-10

    Integra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage

    Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.

    Product
    Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2015·2014-11-19

    Integra Titan Reverse Shoulder System Cutting Templates Recalled for Manufacturing Error

    Integra LifeSciences Corp. is recalling 12 units of Reverse Shoulder System cutting templates because the threaded handle was welded backwards, resulting in an incorrect cutting angle.

    Product
    Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the hume
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0201-2015·2014-11-19

    Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues

    Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.

    Product
    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2182-2014·2014-08-20

    Integra Recalls NewPort MIS System Due to Potential Component Mixing

    Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.

    Product
    Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2072-2014·2014-07-23

    Integra Recalls Camino ICP Catheters for MRI Safety Labeling

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.

    Product
    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1961-2014·2014-07-09

    Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment

    Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.

    Product
    MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1976-2014·2014-07-09

    Integra LED Battery Charger Recalled for Premature Failure

    Integra LifeSciences is recalling 1,250 LED battery chargers because they may fail prematurely and not charge the LED battery as intended.

    Product
    Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1868-2014·2014-07-02

    Integra Recalls Accell Evo3C Bone Matrix Due to Packaging Error

    Integra LifeSciences is recalling 61 units of Accell Evo3C Demineralized Bone Matrix because they were incorrectly packaged in boxes for a different product, creating a risk of improper surgical use.

    Product
    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2014·2014-06-11

    Integra Licox Test Kit Recall for Erroneous Calibration Messages

    Integra LifeSciences is recalling Licox Test Kits that may display false calibration failure messages or out-of-range results when used with specific PtO2 monitors.

    Product
    Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific elec
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1522-2014·2014-05-07

    Integra CUSA Excel Disposable Wrench Recalled for Incorrect Assembly

    Integra LifeSciences is recalling CUSA Excel Disposable Wrenches because some units were incorrectly assembled with the wrong hex wrench insert.

    Product
    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the steril
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2014·2014-02-26

    Integra CUSA Excel CEM Nosecone Recalled for Sticking Button

    Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.

    Product
    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2014·2014-02-19

    Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage

    Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.

    Product
    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical impl
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0621-2014·2014-01-15

    Integra Small Rickham-Style Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 194 packages of Small Rickham-Style Reservoirs due to bent or broken connectors found after opening the sterile package.

    Product
    Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining C
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0622-2014·2014-01-15

    Integra Rickham Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 78 packages of Rickham-Style Reservoirs due to bent or broken connectors found after opening sterile packages.

    Product
    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining C
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0602-2014·2014-01-08

    Integra Camino Advanced Monitor Recalled for Reversed Pressure Display

    Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.

    Product
    Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0210-2014·2013-11-20

    Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues

    Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.

    Product
    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position w
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0060-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 0853
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may not loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro,
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.