Integra LifeSciences Corp. recalls
6 recalls on record · FDA
Every recall we have on record for Integra LifeSciences Corp., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator,…
Possibility for the obturator to break (separate).
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel …
Potential that the induction seal is not completely sealed to the device tube packaging.
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical…
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
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For…
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.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral…
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
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the…
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