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U.S. Department of Health and Human Services

Class 3 Device Recall One Step

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 Class 3 Device Recall One Stepsee related information
Date Initiated by FirmJuly 25, 2025
Date PostedOctober 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0226-2026
Recall Event ID 97350
510(K)NumberK222472 
Product Classification Multiple use blood lancet for single patient use only - Product Code QRL
ProductOne Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Code Information UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Recalling Firm/
Manufacturer		 Home Health US, Incorporated
7672 15th St E
Sarasota FL 34243-3213
For Additional Information ContactLuca Hanson
941-302-0572
Manufacturer Reason
for Recall		Due to incorrect/lack of Unique Device Identifier (UDI) codes.
FDA Determined
Cause 2		Error in labeling
ActionOn 07/25/2025, the firm indicated that they notified Amazon of the recall (mis-labeling) and Amazon has returned affected products that Amazon had in their possession.
Quantity in Commerce4,661 lancets
DistributionU.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/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.
510(K) Database510(K)s with Product Code = QRL
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