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.

201–217 of 217

  • ModerateFDA (Devices)·Z-0054-2014·2013-10-30

    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 Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2014·2013-10-30

    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 Complete Brain Probe Kit REF IM3.ST_.EU 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
  • ModerateFDA (Devices)·Z-0062-2014·2013-10-30

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

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

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU 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
  • ModerateFDA (Devices)·Z-0056-2014·2013-10-30

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

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

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0057-2014·2013-10-30

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

    Integra LifeSciences is recalling 109 Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0059-2014·2013-10-30

    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 fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S 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
  • ModerateFDA (Devices)·Z-0061-2014·2013-10-30

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

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

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU 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
  • SevereFDA (Devices)·Z-1685-2013·2013-07-17

    Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage

    Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.

    Product
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1568-2013·2013-07-03

    Integra LifeSciences Recalls Ascension CMC Saddle Due to Labeling Discrepancies

    Integra LifeSciences is recalling 467 Ascension CMC Saddle implants because the US Instruction for Use contains content discrepancies compared to the FDA-cleared version.

    Product
    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2013·2013-04-24

    Integra XKnife Software Versions 5.0.1 and 5.0.2 Recalled for Beam Plan Error

    Integra LifeSciences Corp. is recalling XKnife software versions 5.0.1 and 5.0.2 due to a software error that may occur when transmitting beam plans.

    Product
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0920-2013·2013-03-20

    Integra CUSA CEM Nosecone Recalled for Potential Tip Erosion

    Integra LifeSciences is recalling CEM Nosecones for the CUSA EXcel system due to a potential for tip erosion and breakage. No patient injuries have been reported.

    Product
    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0886-2013·2013-03-06

    Integra Jarit Monopolar Cable Recall for Updated Safety Warnings

    Integra LifeSciences is recalling 22,500 Jarit Monopolar Cables to distribute an addendum to the Instructions for Use. The update emphasizes existing warnings and adds new precautions for electrosurgical equipment.

    Product
    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2013·2013-02-27

    Integra MAYFIELD Composite Base Units Recalled for Potential Breakage

    Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.

    Product
    MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical p
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2123-2012·2012-08-08

    Integra Advansys Medial Lisfranc Plate Recalled for Surgical Technique Risk

    Integra LifeSciences is recalling Advansys Medial Lisfranc Plates because an incorrect surgical technique may cause potential rupture of the tibialis anterior tendon.

    Product
    Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthr
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1984-2012·2012-07-18

    Integra Pudenz Flushing Valve Recalled for Incorrect Labeling

    Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.

    Product
    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1796-2012·2012-06-20

    Integra Mozaik Putty Recalled for Incorrect Instructions for Use Translation

    Integra LifeSciences Corp. is recalling 42 units of Mozaik Putty because the Instructions for Use contain incorrect Spanish and French translations of the term 'bone marrow aspirate'.

    Product
    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1795-2012·2012-06-20

    Integra Mozaik Strip Recalled for Incorrect Instructions for Use Translation

    Integra LifeSciences Corp. is recalling Integra Mozaik Strip units because the Instructions for Use contain incorrect Spanish and French translations of the term "bone marrow aspirate."

    Product
    Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal
    Category
    Medical Device
    Distribution
    0 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.