PlainRecalls

Integra LifeSciences Corp.

Compiled from official public sources by the editorial team.

217 recalls on record · Latest: Mar 12, 2025

Integra LifeSciences Corp. Recall Insight

Integra LifeSciences Corp. appears on 217 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.213% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 12, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 49 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Oct 30, 2013 to May 16, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 16, 2018

Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound hea…

FDA Devices Moderate May 2, 2018

TCC-EZ, Total Contact Cast System, Model No. TCC2-4051

FDA Devices Moderate May 2, 2018

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description …

FDA Devices Moderate Mar 7, 2018

Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of t…

FDA Devices Moderate Mar 29, 2017

Panta Nail, Rx only, Sterile,

FDA Devices Low Mar 15, 2017

The UNI-CP System; Model Number: 330230SND.

FDA Devices Moderate Feb 22, 2017

Integra Cadence Total Ankle System

FDA Devices Moderate Oct 12, 2016

Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to…

FDA Devices Moderate Oct 12, 2016

Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and ter…

FDA Devices Moderate Oct 12, 2016

Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardbo…

FDA Devices Moderate Oct 12, 2016

Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a…

FDA Devices Moderate Oct 12, 2016

CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Fiv…

FDA Devices Moderate Oct 12, 2016

Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to…

FDA Devices Moderate Sep 14, 2016

Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat ac…

FDA Devices Moderate Aug 31, 2016

Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of…

FDA Devices Moderate Aug 17, 2016

Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixatio…

FDA Devices Moderate Aug 17, 2016

Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

FDA Devices Moderate Aug 3, 2016

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of e…

FDA Devices Moderate Jul 6, 2016

Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing…

FDA Devices Moderate Jul 6, 2016

K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannul…

FDA Devices Moderate Jun 22, 2016

TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the c…

FDA Devices Moderate Jun 8, 2016

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

FDA Devices Moderate Jun 8, 2016

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

FDA Devices Moderate Oct 14, 2015

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the I…

FDA Devices Moderate Jun 24, 2015

Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring…

FDA Devices Moderate May 27, 2015

The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tippe…

FDA Devices Moderate May 27, 2015

The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tippe…

FDA Devices Moderate May 27, 2015

The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tippe…

FDA Devices Moderate Apr 22, 2015

Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wou…

FDA Devices Moderate Dec 24, 2014

Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, C…

FDA Devices Moderate Dec 24, 2014

Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarso…

FDA Devices Moderate Dec 10, 2014

Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator …

FDA Devices Moderate Nov 19, 2014

Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County…

FDA Devices Moderate Nov 19, 2014

Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 de…

FDA Devices Moderate Aug 20, 2014

Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) Th…

FDA Devices Moderate Jul 23, 2014

Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

FDA Devices Moderate Jul 9, 2014

Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Hea…

FDA Devices Moderate Jul 9, 2014

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 (8…

FDA Devices Moderate Jul 2, 2014

Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized …

FDA Devices Moderate Jun 11, 2014

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 …

FDA Devices Moderate May 7, 2014

Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ S…

FDA Devices Moderate Feb 26, 2014

Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical A…

FDA Devices Moderate Feb 19, 2014

Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K06…

FDA Devices Moderate Jan 15, 2014

Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made…

FDA Devices Moderate Jan 15, 2014

Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made…

FDA Devices Moderate Jan 8, 2014

Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Adv…

FDA Devices Moderate Nov 20, 2013

Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid …

FDA Devices Moderate Oct 30, 2013

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, S…

FDA Devices Moderate Oct 30, 2013

Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische,…

FDA Devices Moderate Oct 30, 2013

Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizin…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Integra LifeSciences Corp. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.