Princeton, NJ, United States
Integra LifeSciences Corp. (NeuroSciences) recalls
13 recalls recorded since 2018, most recently on 5 June 2026. 13 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)13
Terminated or completed0
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 5 June 2026
- Reason
- 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 the sterilization cycle exposure time used.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, J
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2714-2026
- OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Ongoing Class II Medical devices
- Recall started
- 10 April 2026
- Reason
- Out-of-specification endotoxin result that did not meet the acceptance criteria.
- Distribution
- US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2173-2026
- Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal f
Ongoing Class II Medical devices
- Recall started
- 19 March 2026
- Reason
- Increased rate of out-of-specification endotoxin results.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1820-2026, Z-1816-2026, Z-1819-2026, Z-1817-2026, Z-1818-2026
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
- Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
- Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
- Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
- Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Ongoing Class II Medical devices
- Recall started
- 6 March 2026
- Reason
- Software issue that renders the touch screen unresponsive.
- Distribution
- Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1828-2026
- CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Ongoing Class II Medical devices
- Recall started
- 16 January 2026
- Reason
- Potential packaging failures, which could lead to a breach in the sterile barrier.
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1363-2026, Z-1365-2026, Z-1364-2026
- MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated
- Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
- MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement a
Ongoing Class II Medical devices
- Recall started
- 12 December 2025
- Reason
- Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1036-2026, Z-1037-2026
- Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal
- Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nyl
Ongoing Class II Medical devices
- Recall started
- 3 October 2025
- Reason
- 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 visual verification of device location within the patient s anatomy.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0420-2026
- TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Ongoing Class I Medical devices
- Recall started
- 26 September 2025
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherla
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0373-2026, Z-0374-2026
- CODMAN Disposable Perforator 11mm. Cranial Perforator.
- CODMAN Disposable Perforator 9mm. Cranial Perforator.
Ongoing Class II Medical devices
- Recall started
- 5 August 2025
- Reason
- Packaging failures were identified which could lead to a breach in the sterile barrier.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2505-2025, Z-2512-2025, Z-2508-2025, Z-2507-2025, Z-2509-2025, Z-2506-2025, Z-2511-2025, Z-2510-2025
- Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grad
- Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist
- Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist woun
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made o
- Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum me
- Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dr
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing
Ongoing Class I Medical devices
- Recall started
- 23 May 2025
- Reason
- Lack of sterility assurance.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland a
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1961-2025
- MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Ongoing Class I Medical devices
- Recall started
- 22 May 2025
- Reason
- Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Be
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1959-2025, Z-1958-2025, Z-1960-2025
- Extended Tip Applicator, 15 CM, Box of 5.
- Extended Tip Applicator, 8CM, Box of 5.
- Extended Tip Applicator 8CM, Box of 1.
Ongoing Class I Medical devices
- Recall started
- 11 April 2025
- Reason
- Inadequate weld that can potentially cause the product to disassemble.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, I
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1717-2025, Z-1716-2025
- CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
- CODMAN Disposable Perforator, 14mm. Cranial perforator.
Ongoing Class II Medical devices
- Recall started
- 4 April 2025
- Reason
- Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1724-2025
- INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.