Class II — Potential Health Hazard

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

Bright Embrace Recalled by Physician Engineered Products, Inc. Due to Upper limit for ambient temperature for use of...

Date: August 31, 2013
Company: Physician Engineered Products, Inc.
Status: Terminated
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 Physician Engineered Products, Inc. directly.

Affected Products

Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

Quantity: 97 units

Why Was This Recalled?

Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

Where Was This Sold?

This product was distributed to 11 states: CA, CO, FL, KY, MD, MA, NM, PA, TN, TX, VA

Affected (11 states)Not affected

About Physician Engineered Products, Inc.

Physician Engineered Products, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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