Integra LifeSciences Corp.: Device Recall

Recall #Z-1295-2025 · 02/06/2025

Class II: Risk

Recall Details

Recall Number: Z-1295-2025
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp.
Status: Ongoing
Date Initiated: 02/06/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 623 units

Reason for Recall

Possibility for the obturator to break (separate).

Product Description

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

Distribution Pattern

US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.

Other Recalls by Integra LifeSciences Corp.

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.
Class II: Risk 09/26/2024

Out of specification endotoxin levels.

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.