Integra LifeSciences Corp.: Device Recall

Recall #Z-2331-2024 · 06/07/2024

Class II: Risk

Recall Details

Recall Number: Z-2331-2024
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp.
Status: Ongoing
Date Initiated: 06/07/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14 units

Reason for Recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Product Description

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Distribution Pattern

Domestic: NY, OH, & DC.

Other Recalls by Integra LifeSciences Corp.

Class II: Risk 02/06/2025

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

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

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

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

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →

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.