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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:
March 12, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ
Hazard: Possibility for the obturator to break (separate).
February 19, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve
Hazard: Potential that the induction seal is not completely sealed to the device tube packaging.
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provid
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Hazard: Out of specification endotoxin levels.
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in pr
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in prote
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in prote
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in p
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in pro
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in pr
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in pr
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in pro
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in p
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use i
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use i
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the u
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use i
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use i
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the us
Hazard: 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
November 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of CO
Hazard: 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
October 16, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)
Hazard: There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
August 14, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wi
Hazard: 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.