Class 2 Device Recall UVILIZER Flip (Model Seago SG153)

• Date Initiated by Firm: January 27, 2022
• Date Posted: October 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0003-2023
• Recall Event ID: 90860
• Product Classification: Uv lamp, germicidal - Product Code RHP
• Product: The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
• Code Information: Model Seago SG-153
• FEI Number: 3016850352
• Recalling Firm/ Manufacturer: IN MY BATHROOM LLC; 22617 Mariano St; Woodland Hills CA 91367-6127
• For Additional Information Contact: 747-242-7854
• Manufacturer Reason for Recall: Excessive ultraviolet-C radiation
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: The firm issued and Urgent Electronic Device Recall letter dated September 9, 2022. Please complete and return the Electronic Device Recall Return Response form below as soon as possible to acknowledge receipt of this letter and initiate the process of sending back your UVILIZER Flip (Model Seago SG-153).
• Quantity in Commerce: 485 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.