Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854…
Reason for recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- One 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 forearmUDIUDI-DI code7 affected lots23122908020694951700885428g24063102010694951700884723g2406310201
What the firm is doing
On 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.
DistributionShow detailsHide
U.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
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0226-2026
- FDA 510(k) clearance · K222472The device's official FDA premarket clearance record
- FDA device classification · QRLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4850The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Home Health US, IncorporatedSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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