Every recall we track for Integra LifeSciences Corp. — 154 in all — plus the complaints and injury reports the public filed about them.
Integra LifeSciences recalls AURORA Surgiscope System (models ASX15/60 and ASX15/80) due to possible obturator separation. This single-use surgical device may break during use, causing injury. Affected units include all unexpired lots.
Integra LifeSciences recalls MediHoney Wound & Burn Dressing Gel (model 31815) due to potential unsealed packaging. This could lead to contamination risks for wound care. Affected units include specific lot numbers.
Integra LifeSciences recalls specific CODMAN CERTAS Plus Programmable Valve models due to incorrect labeling on internal and external labels, which may lead to improper use.
Integra LifeSciences recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve (Model 828810) due to incorrect labeling on some SKUs and lot numbers. Affected units may have wrong product descriptions on internal and external labels.
Integra LifeSciences recalls specific Duraform Dural Graft Implant (Model 80-147: Lot CT007694) due to potential endotoxin levels outside specifications. Affected patients should contact for guidance.
Integra recalls SURG PAT XRAY 1X1 Model 801403 surgical patties and strips due to potential endotoxin levels exceeding specifications, which could pose risks during surgery.
Integra LifeSciences recalls SURG STRP 1/4X6 Model 80145: Higher endotoxin levels in surgical products may pose health risks during surgery. Affected products have UDI numbers 10381780515067 and 20886704036583.
Integra recalls SURG PAT XRAY 1/2X3 Model 801407 surgical patties and strips due to potential endotoxin levels exceeding safety standards. These products are used in brain and nervous system surgeries. Unexpired products may be affected.
Integra recalls SURG PAT XRAY 1/4X1-1/2 Model 801397 surgical patties and strips due to potential endotoxin levels in finished goods that could affect surgical safety.
Integra recalls Codman Surgical Patties and Strips (model 801396) due to potential endotoxin levels exceeding specifications in finished products. Affected items may pose a risk during surgery.
Integra recalls SURG STRP 1X6-200 surgical strips due to potential endotoxin levels in finished products that could cause infection during surgery.
Integra recalls SURG STRP 2X6 surgical patties and strips with potential endotoxin levels exceeding safety standards. These products are used in brain and nervous system surgeries. Affected units have specific UDI numbers.
Integra recalls SURG STRP 3/4X6 surgical strips with model 801452 due to potential endotoxin levels in finished products that could cause infection during surgery.
Integra recalls SURG PAT XRAY 1/4X1/4 Model 801399 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may pose risks during surgery.
Integra recalls SURG PAT XRAY 3/4X3/4 Model 801401 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may have out-of-specification endotoxin levels.
Integra recalls SURG PAT XRAY 1/2X1-1/2 Model 801404 surgical patties and strips due to potential endotoxin levels in finished goods that could affect surgical safety.
Integra recalls SURG PAT XRAY 1X3 Model 801408 surgical patties and strips due to potential endotoxin levels in finished goods. This may affect surgical use during procedures involving brain or nervous system tissue.
Integra recalls SURG PAT XRAY 3X3 Model 801409 surgical patties and strips due to potential endotoxin levels exceeding specifications, which could pose risks during surgery.
Integra LifeSciences recalls SURG STRP 1-1/ 2X6 Model 801454 due to potential endotoxin levels in finished surgical products. Affected items may pose a risk during surgery. Consumers should contact Integra for details.
Integra recalls SURG PAT XRAY 1/2X2 Model 801406 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may pose risks during surgery.
Integra LifeSciences recalls MEDIHONEY Dressing with Active Leptospermum Honey wound and burn dressings (Model 31515/31535) due to potential pinholes in the applicator pouch film that could compromise sterility.
Integra recalls specific lots of TruDi NAV Suction instruments (TDNS000Z) for potential calibration errors that could cause surgical location mismatches when used with the TruDi Navigation System.
Integra LifeSciences recalls AURORA Surgiscope System due to potential sheath damage causing tissue injury or bleeding. Affected units have specific model and lot numbers.
Integra recalls CUSA Excel 23KHz handpieces made before Nov 2023 due to potential housing cracks causing treatment delays. Affected units have specific serial numbers and manufacturing dates.
Integra LifeSciences recalls CODMAN EVD BACTISEAL 1.9mm catheter sets due to potential packaging defects that could compromise sterility. Affected units include specific lot numbers and product codes.
Integra LifeSciences recalls Bactisal Clear EVD Catheter sets with packaging defects that could compromise sterility. Affected units include specific lot numbers and product codes for brain ventricle access procedures.
Integra LifeSciences recalls Bactisal EVD catheter sets with packaging defects that may compromise sterility. Affected units include specific lot numbers and product codes for brain ventricle access procedures.
Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging tears that could compromise sterility during ventriculostomy procedures.
Integra LifeSciences recalls Cranial Access Kits with potential sterility issues due to defective packaging. Affected units have specific lot numbers and expiration dates. Consumers should contact Integra for details.
Integra LifeSciences recalls Cranial Access Kits with defective sterile packaging that may compromise product sterility. Affected kits have specific lot numbers and expiration dates. Consumers should contact Integra for details.
Integra recalls cranial access kits with potential sterility compromise due to packaging defects. Affected units include specific lot numbers and expiration dates. Consumers should contact Integra for details.
Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging defects that could compromise sterility. Affected units have specific lot numbers and expiration dates.
Integra LifeSciences recalls INS7280 Cranial Access Kit due to potential sterility compromise from defective packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details.
Integra LifeSciences recalls a cranial access kit combo (INS-8301, INS-4500, INS-HITH) due to potential sterility compromise from defective packaging. Affected units have UDI 10381780178255 and lot 7281021 expiring April 1, 2024.
Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7250) due to potential sterility compromise from defective packaging. Affected units sold with specific lot numbers and expiration dates.
Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7270) due to potential sterility compromise from defective packaging. Affected units sold with lot number 7257036 expiring 1-Sep-24.
Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7260) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers sold through medical channels.
Integra recalls Cranial Access Kit (Ref No: HITHSP04) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers and expiration dates.
Integra LifeSciences recalls cranial access kits (without prep solutions) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers and expiration dates. Consumers should contact Integra for details.
Integra LifeSciences recalls cranial access kits (model 10-110/INS-4500/INS-7040) due to packaging defect that could compromise sterility. Affected units have catalog number 31004 and lot 6926457. No remedy specified in recall notice.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without external force, risking sterility. Affected units have specific catalog numbers and expiration dates.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates. Consumers should contact Integra for details.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates.
Integra recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without external force, risking sterility. Affected kits have specific catalog numbers and expiration dates.
Integra recalls cranial access kits (without prep solutions) due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates. Consumers should contact Integra for details.
Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have catalog number INS7040 and were sold with lot number 6837706 through March 2025.
Integra LifeSciences recalls CereLink ICP Extension Cable Model 826845 due to potential out of range readings. Affected units sold with Codman CereLink ICP monitors.
Integra LifeSciences recalls Codman Cranial Hand Drills with rust in drill chuck that may cause inflammation, infection, or surgery delays. Affected units have specific part numbers and lot numbers.
Integra LifeSciences recalls Codman Surgical Patties (part 801400, lot 6396457) due to possible minor fever from endotoxin issues. Affected units may cause temporary fever during surgery.
Integra recalls CereLink ICP monitors with catalog numbers 826820 and 826820P due to potential ICP readings drifting to -50 mmHg, which could trigger error messages.
