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Integra LifeSciences Recalls
246 recalls on record · June 20, 2012 to March 12, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 17, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Hazard: Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
July 3, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a
Hazard: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
June 19, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain
Hazard: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
June 19, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be use
Hazard: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
June 19, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with di
Hazard: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
May 29, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu
Hazard: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the b
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid s
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brai
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Hazard: 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.
March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ven
Hazard: 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.
December 20, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP
Hazard: 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 address the "out of range readings" issue.
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the br
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe
Hazard: 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
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ve
Hazard: 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
May 31, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monit
Hazard: 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, inconvenience to user, and/or infection.
January 18, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Hazard: 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.
August 3, 2022Medical DevicesFDA
Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Hazard: 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 electrical interference from a component of the monitor's circuit board and from the environment.