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U.S. Department of Health and Human Services

Class 2 Device Recall UltravioletC sanitizer wand model HH1103/HDUV01PL03 (SKU BTGERMWANDLRGWHT)

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 Class 2 Device Recall UltravioletC sanitizer wand model HH1103/HDUV01PL03 (SKU BTGERMWANDLRGWHT)see related information
Date Initiated by FirmAugust 29, 2025
Date PostedSeptember 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2571-2025
Recall Event ID 97621
Product Classification Uv lamp, germicidal - Product Code RHP
ProductThe product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Code Information SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
FEI Number 3039602167
Recalling Firm/
Manufacturer		 BigTree Sales Inc.
11715 Clark St
Arcadia CA 91006-5806
Manufacturer Reason
for Recall		The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionBigTree Sales, Inc. notified FDA and their customers as required by 21 CFR 1003.10(b), that their electronic product, Portable UV-C Light Sanitizer Wand/Travel UV Sanitizing Wand, model: HH1103/HD-UV-01PL03 (SKU BT-GERMWAND-LRG-WHT), has been discovered to contain a defect related to its safety. Their customer letter was sent with the knowledge of the U.S. Food and Drug Administration (FDA).
DistributionU.S.A
Total Product Life CycleTPLC 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.
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