Integra LifeSciences Corp.

36 FDA enforcement actions

36 Total Recalls

0 Class I

36 Class II

0 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 02/06/2025 device

Possibility for the obturator to break (separate).
Class II: Risk 01/10/2025 device

Potential that the induction seal is not completely sealed to the device tube packaging.
Class II: Risk 12/16/2024 device

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024 device

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024 device

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 09/26/2024 device

Out of specification endotoxin levels.
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/20/2024 device

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
Class II: Risk 09/13/2024 device

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Class II: Risk 07/09/2024 device

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 location displayed on the system.
Class II: Risk 06/07/2024 device

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Class II: Risk 05/29/2024 device

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Class II: Risk 05/07/2024 device

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Class II: Risk 05/07/2024 device

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Class II: Risk 05/07/2024 device

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Class II: Risk 04/17/2024 device

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.