Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AURORA Surgiscope System. Sterile Recalled by Integra LifeSciences Corp. Due to Potential sheath damage that could lead to tissue...

Date: June 7, 2024
Company: Integra LifeSciences Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

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

Quantity: 14 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: NY, OH, DC

Affected (3 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report