Integra LifeSciences Corp. recalls
Every recall we track for Integra LifeSciences Corp. — 154 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Integra LifeSciences Corp. fell by more than half in 2025 (2, down from 45 in 2024).
All FDA recall records for Integra LifeSciences Corp. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 2 | 1 | 0 | 3 |
| 2018 | 0 | 4 | 1 | 0 | 5 |
| 2019 | 0 | 1 | 73 | 0 | 74 |
| 2020 | 0 | 3 | 4 | 0 | 7 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 5 | 0 | 5 |
| 2023 | 0 | 1 | 9 | 1 | 11 |
| 2024 | 0 | 3 | 38 | 4 | 45 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Integra LifeSciences Corp. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Integra LifeSciences Corp. recalls
36 shown- Lower riskMedical device
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's
Integra LifeSciences recalls AURORA Surgiscope System (models ASX15/60 and ASX15/80) due to possible obturator separation. This single-use surgical device may break during use, causing injury. Affected units include all unexpired lots.
Integra LifeSciencesFeb 6, 2025 - Lower riskMedical device
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software
Integra LifeSciences recalls MediHoney Wound & Burn Dressing Gel (model 31815) due to potential unsealed packaging. This could lead to contamination risks for wound care. Affected units include specific lot numbers.
MediHoneyJan 10, 2025 - Lower riskMedical device
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides
Integra LifeSciences recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve (Model 828810) due to incorrect labeling on some SKUs and lot numbers. Affected units may have wrong product descriptions on internal and external labels.
Integra LifeSciencesDec 16, 2024 - UnratedMedical device
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Integra LifeSciences recalls specific Duraform Dural Graft Implant (Model 80-147: Lot CT007694) due to potential endotoxin levels outside specifications. Affected patients should contact for guidance.
Integra LifeSciencesSep 26, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in
Integra recalls SURG PAT XRAY 1/2X2 Model 801406 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may pose risks during surgery.
IntegraSep 20, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)
Integra LifeSciences recalls MEDIHONEY Dressing with Active Leptospermum Honey wound and burn dressings (Model 31515/31535) due to potential pinholes in the applicator pouch film that could compromise sterility.
Integra LifeSciencesSep 13, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with
Integra recalls specific lots of TruDi NAV Suction instruments (TDNS000Z) for potential calibration errors that could cause surgical location mismatches when used with the TruDi Navigation System.
IntegraJul 9, 2024 - Use cautionMedical device
Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Integra LifeSciences recalls AURORA Surgiscope System due to potential sheath damage causing tissue injury or bleeding. Affected units have specific model and lot numbers.
Integra LifeSciencesJun 7, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification
Integra recalls CUSA Excel 23KHz handpieces made before Nov 2023 due to potential housing cracks causing treatment delays. Affected units have specific serial numbers and manufacturing dates.
IntegraMay 29, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with
Integra LifeSciences recalls Bactisal EVD catheter sets with packaging defects that may compromise sterility. Affected units include specific lot numbers and product codes for brain ventricle access procedures.
Integra LifeSciencesMay 7, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog
Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging tears that could compromise sterility during ventriculostomy procedures.
IntegraApr 17, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid
Integra LifeSciences recalls cranial access kits (without prep solutions) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers and expiration dates. Consumers should contact Integra for details.
IntegraJan 19, 2024 - Lower riskMedical device
Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have catalog number INS7040 and were sold with lot number 6837706 through March 2025.
IntegraOct 19, 2023 - Lower riskMedical device
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP)
Integra LifeSciences recalls CereLink ICP Extension Cable Model 826845 due to potential out of range readings. Affected units sold with Codman CereLink ICP monitors.
Integra LifeSciencesOct 5, 2023 - Use cautionMedical device
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP)
Integra LifeSciences recalls Codman Cranial Hand Drills with rust in drill chuck that may cause inflammation, infection, or surgery delays. Affected units have specific part numbers and lot numbers.
Integra LifeSciencesApr 11, 2023 - Lower riskMedical device
Integra LifeSciences Corp. recalls Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences recalls Codman Surgical Patties (part 801400, lot 6396457) due to possible minor fever from endotoxin issues. Affected units may cause temporary fever during surgery.
Integra LifeSciencesDec 2, 2022 - Lower riskMedical device
Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra recalls CereLink ICP monitors with catalog numbers 826820 and 826820P due to potential ICP readings drifting to -50 mmHg, which could trigger error messages.
IntegraJun 22, 2022 - Lower riskMedical device
Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Integra recalls Universal Flexible Arm part REF 1362275 due to cable breakage from excessive tightening. Affected units include specific lots and UDI numbers. No remedy provided in official notice.
IntegraFeb 28, 2022 - Lower riskMedical device
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP)
Integra LifeSciences recalls Codman Cranial Access Kits with incorrect expiration dates on outer box labels. Using past expiration date may cause pain, infection, or adverse tissue reactions. Affected kits have specific part and lot numbers.
Integra LifeSciencesJan 21, 2022 - Lower riskMedical device
Integra LifeSciences Corp. recalls CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part
Integra LifeSciences recalls disposable scalp clips with wrinkled packaging that could compromise sterile barrier. Affected units include specific part numbers and lot numbers. Consumers should check packaging for wrinkles and contact Integra for details.
Integra LifeSciencesJun 1, 2021 - Lower riskMedical device
Integra LifeSciences Corp. recalls CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and
Integra LifeSciences recalls CODMAN HAK: BACTISEAL shunt systems with incorrect labeling that may affect peritoneal catheter function. Learn if your device is affected and what to do.
Integra LifeSciencesMar 17, 2021 - Lower riskMedical device
Integra LifeSciences Corp. recalls Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a
Integra LifeSciences recalls Bactise:al Ventricular Catheter (823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087). This could lead to incorrect use in hydrocephalus treatment. Affected units: Lot 4178253, exp. Nov 2019.
Integra LifeSciencesDec 14, 2020 - Lower riskMedical device
Integra LifeSciences Corp. recalls Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during
Integra LifeSciences recalls revised instruction manuals for Mayfield A2000 skull cap. The update corrects illustrations for neurosurgical use to ensure safe rigid skeletal fixation.
Integra LifeSciencesNov 11, 2020 - Use cautionMedical device
Integra LifeSciences Corp. recalls Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic
Integra recalls specific models of dermatome sets used in plastic surgery due to handpiece cable melting after sterilization. Affected units must be checked for melted cables and disposed of safely.
IntegraAug 4, 2020 - Lower riskMedical device
Integra LifeSciences Corp. recalls NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated
Integra LifeSciences recalls NeuraGen nerve guides with part number PNG72 due to nonconforming product mistakenly released for commercial use. Affected units include specific lot numbers.
IntegraFeb 7, 2020 - Lower riskMedical device
Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra recalls C7000 Clarity Ultrasonic Tissue Ablation System due to 30-minute drying cycle not meeting required 40-minute dry time for sterilization trays, risking incomplete sterilization.
Integra LifeSciencesOct 21, 2019 - Lower riskMedical device
Integra LifeSciences Corp. recalls Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type
Integra LifeSciences recalls Cerelink ICP Monitor model 826820 due to potential progressive decline in observed ICP readings during use. Affected users should contact the company for details.
Integra LifeSciencesSep 12, 2019 - Lower riskMedical device
Integra LifeSciences Corp. recalls Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding
Integra recalls 9 1/4 inch GEMINI CLAMP for possible corrosion after multiple sterilizations, requiring replacement to prevent breakage during medical procedures.
IntegraAug 7, 2019 - Lower riskMedical device
Integra LifeSciences Corp. recalls Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during
Integra recalls Codman ISOCOOL Bipolar Forceps model 8145100S with inadequate tip insulation that may cause improper tissue coagulation during surgery.
IntegraJul 19, 2019 - Use cautionMedical device
Integra LifeSciences Corp. recalls MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF
Integra LifeSciences recalls MoniTorr INS1100 CSF Drainage Systems used with Pole Mount System due to reported breakage of transducer mount stopcocks. Affected patients should stop using the device immediately.
Integra LifeSciencesApr 8, 2019 - Lower riskMedical device
Integra LifeSciences Corp. recalls Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Integra LifeSciences recalls specific Talar Dome Total Ankle Prostheses due to incorrect metal coating labeling on implant labels and instructions. Affected units may have safety risks.
Integra LifeSciencesMar 8, 2019 - Use cautionMedical device
Integra LifeSciences Corp. recalls MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be
Integra recalls MAYFIELD Infinity XR2 Base Unit adaptors (part A2600R) due to potential knob fracture during use. Affected units sold from 2018-2023; check serial numbers listed.
IntegraJun 29, 2018 - Lower riskMedical device
Integra LifeSciences Corp. recalls Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to
Integra LifeSciences recalls Manuka Honey Wound Gel (Catalogue No: 716:597) due to an incorrect gel part number in manufacturing records. This may affect wound healing for minor injuries.
Integra LifeSciencesMar 6, 2018 - Use cautionMedical device
Integra LifeSciences Corp. recalls The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog
Integra LifeSciences recalls humeral stem trials for Titan Modular Shoulder System due to reported breakage during insertion or extraction, causing delays in surgery. Affected items include specific catalog numbers and lot numbers.
Integra LifeSciencesDec 20, 2017 - Use cautionMedical device
Integra LifeSciences Corp. recalls Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The
Integra LifeSciences recalls Footswitch (C7000) for CUSA Clarity system due to risk of unintended ultrasonic tissue fragmentation during surgery. Affected units include specific lots.
Integra LifeSciencesSep 26, 2017 - Lower riskMedical device
Integra LifeSciences Corp. recalls TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Integra LifeSciences recalls TCC-EZ Total Contact Cast System Model TCC2-4051 due to potential overheating from increased exothermic reactions. Affected units sold in specific lots may exceed safety specifications.
Integra LifeSciencesAug 18, 2017
Integra LifeSciences Corp. recall questions
How many recalls has Integra LifeSciences Corp. had?
154 recalls from Integra LifeSciences Corp. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Integra LifeSciences Corp. recall?
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's, dated Feb 6, 2025. Every Integra LifeSciences Corp. recall is listed on this page, newest first.
What should I do if I have a recalled Integra LifeSciences Corp. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Integra LifeSciences Corp. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.