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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97350

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 25, 2025
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Home Health US, Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 forearm.

Z-0226-2026
Recall number
Z-0226-2026
Initiated
July 25, 2025
Classification
Class III
Status
Ongoing
Quantity
4,661 lancets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to incorrect/lack of Unique Device Identifier (UDI) codes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Code information

UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201

Distribution pattern

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