Integra LifeSciences recalls
33 official recalls and safety alerts involving Integra LifeSciences since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Integra LifeSciences or the relevant agency.
- 2026-07-15
USIntegra LifeSciences Corp. (NeuroSciences) recalls OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on…
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2026-05-20
- US
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD…
Out-of-specification endotoxin result that did not meet the acceptance criteria.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR),…Official notice → - 2026-04-29
- US
Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Software issue that renders the touch screen unresponsive.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution in the states of MI & NY. The countries…Official notice → - 2026-04-22
- US
Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL,…Official notice → - 2026-02-25
- US
Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing…
Potential packaging failures, which could lead to a breach in the sterile barrier.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO,…Official notice → - 2026-01-14
- US
Integra LifeSciences Corp. (NeuroSciences) recalls Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when…
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - 2025-11-12
- US
Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F…
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for…
- US
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-09-10
- US
Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…
Packaging failures were identified which could lead to a breach in the sterile barrier.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-07-02
- US
Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow…
Lack of sterility assurance.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide and the countries of Taiwan (Province…Official notice → - US
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New…Official notice → - 2025-05-14
- US
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of TX, MT, AL & OK.Official notice → - US
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - 2025-03-12
- US
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers…
Possibility for the obturator to break (separate).
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA,…Official notice → - 2025-02-19
- US
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A…
Potential that the induction seal is not completely sealed to the device tube packaging.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-01-29
- US
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA,…Official notice → - 2024-11-06
- US
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Out of specification endotoxin levels.
- US
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 protection of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great…Official notice → - 2024-10-16
- US
Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube…
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC,…Official notice → - 2024-08-14
- US
Integra LifeSciences Corp. recalls TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi"…
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized…
FDA · DeviceIntegra LifeSciences Corp.The devices are only sold in the US. The following states have received the…Official notice → - 2024-07-17
- US
Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- 2024-07-03
- US
Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration…
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
FDA · DeviceIntegra LifeSciences Corp.Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia…Official notice → - 2024-06-19
- US
Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally…
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the state of TX and the countries of…Official notice → - 2024-05-29
- US
Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of CA, BE, CL.Official notice → - 2024-03-06
- US
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the…
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Austria, Bahamas,…Official notice → - 2023-12-20
- US
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model…
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to…
FDA · DeviceIntegra LifeSciences Corp.US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL…Official notice → - 2023-12-13
- US
Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of…
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-05-31
- US
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay,…
- 2023-01-18
- US
Integra LifeSciences Corp. recalls Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - 2022-08-03
- US
Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by…
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong…Official notice → - 2022-04-20
- US
Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TXOfficial notice → - 2022-03-30
- US
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →