← Every firm
Integra LifeSciences Corp. FDA Recalls
65 recalls on file across devices, 2 of them Class I and 61 still open. Matched by name to IART.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's ProduClass IIFeb 6, 2025Possibility for the obturator to break (separate). |
| Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software VeClass IIJan 10, 2025Potential that the induction seal is not completely sealed t |
| CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides Class IIDec 16, 2024Potential for certain SKUs and lot numbers were distributed |
| CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that providClass IIDec 16, 2024Potential for certain SKUs and lot numbers were distributed |
| CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides Class IIDec 16, 2024Potential for certain SKUs and lot numbers were distributed |
| Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694Class IISep 26, 2024Out of specification endotoxin levels. |
| SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the useClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in proteClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in prClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use iClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in Class IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in Class IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use iClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in pClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the usClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in proClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in prClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the useClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the uClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in proteClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in pClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use iClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in Class IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use iClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the useClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in proClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in prClass IISep 20, 2024Identified higher-than-expected levels of endotoxin within t |
| MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) Class IISep 13, 2024There is a potential for pinholes in the applicator pouch fi |
| TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wiClass IIJul 9, 2024Specific lots of TruDi NAV Suction Instruments 0 Degrees wer |
| AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.Class IIJun 7, 2024Potential sheath damage that could lead to tissue damage and |
| CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification aClass IIMay 29, 2024Potential for the CUSA Excel 23KHz Straight Handpiece housi |
| CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with diClass IIMay 7, 2024Defect in the external sterile packaging (pouch) leading to |
| CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be useClass IIMay 7, 2024Defect in the external sterile packaging (pouch) leading to |
| CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brainClass IIMay 7, 2024Defect in the external sterile packaging (pouch) leading to |
| Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog NuClass IIApr 17, 2024Potential holes and tears in the sterile packaging (header b |
| Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braiClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid sClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spacClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral venClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.Class IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the braClass IIJan 19, 2024A defect in the sterile packaging (header bag) of the Crania |
| Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral veClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits can |
| Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:Class IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog NumbeClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits can |
| Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:Class IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog NumberClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog NumbeClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog NumberClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog NumberClass IIOct 19, 2023Defect in the outer packaging of the Cranial Access Kits. ca |
| CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICPClass IOct 5, 2023Firm is expanding the existing recall RES 90457 for the Cere |
| Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitClass IIApr 11, 2023Released with discoloration (rust) on the Drill Chuck and in |
| Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457Class IIDec 2, 2022Integra LifeSciences identified that one lot was released wi |
| CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.Class IJun 22, 2022Integra has received complaints associated with ICP readings |
| Integra Universal Flexible Arm part number REF 1362275Class IIFeb 28, 2022Excess force used to tighten the Universal Flexible Arm can |
| Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moniClass IIJan 21, 2022Incorrect extended expiration dates identified on the outer |
| Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moniClass IIJan 21, 2022Incorrect extended expiration dates identified on the outer |
| CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part NumbClass IIJun 1, 2021Packaging-pouches with wrinkles across the Tyvek side may co |
| CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking.Class IIMar 17, 2021Incorrect labeling, Catheter did not have the required holes |