Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Physician Engineered Products, Inc.
- Reason for Recall:
- Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Product Codes/Lot Numbers:
Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)
Distribution:
Distributed in: US, CA, CO, FL, KY, MA, MD, NM, PA, TN, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2486-2015