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 2 Series Recalled by DKK Dai-Ichi Shomei Co., Ltd. Due to The weld on the light head frame can...

Date: July 9, 2024
Company: DKK Dai-Ichi Shomei Co., Ltd.
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 DKK Dai-Ichi Shomei Co., Ltd. directly.

Affected Products

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Quantity: 822 units

Why Was This Recalled?

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DKK Dai-Ichi Shomei Co., Ltd.

DKK Dai-Ichi Shomei Co., Ltd. has 6 total recalls tracked by RecallDetector.

Related Recalls

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