Recall archive
92 recalls · page 1 of 4
Reported Jul 15, 2026
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported May 20, 2026
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Out-of-specification endotoxin result that did not meet the acceptance criteria.
FDA (openFDA device enforcement)
Reported Apr 29, 2026
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Software issue that renders the touch screen unresponsive.
FDA (openFDA device enforcement)
Reported Apr 22, 2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Increased rate of out-of-specification endotoxin results.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2026
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Potential packaging failures, which could lead to a breach in the sterile barrier.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Packaging failures were identified which could lead to a breach in the sterile barrier.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Extended Tip Applicator, 8CM, Box of 5.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
Matched: Brand — Inadequate weld that can potentially cause the product to disassemble.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Possibility for the obturator to break (separate).
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Potential that the induction seal is not completely sealed to the device tube packaging.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted…
22 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in…
FDA (openFDA device enforcement)
Reported Jul 17, 2024
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
FDA (openFDA device enforcement)
Reported Jun 19, 2024
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore,…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
Matched: Brand — Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated…
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the…
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity,…
FDA (openFDA device enforcement)
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