Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91137

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

Open FDA event record

Event summary

Timeline bucket
August 09, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
DEWEI MEDICAL EQUIPMENT CO LTD

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

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Z-0323-2023
Recall number
Z-0323-2023
Initiated
August 09, 2022
Classification
Class I
Status
Ongoing
Quantity
1,348,000 (US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products were distributed in the United States without FDA authorization or clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products were distributed in the United States without FDA authorization or clearance.

Code information

LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22

Distribution pattern

US Distribution in states to: CA, FL, KY, and MI.