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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87575

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

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Event summary

Timeline bucket
February 16, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vectornate USA Inc

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

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

Z-1417-2021
Recall number
Z-1417-2021
Initiated
February 16, 2021
Classification
Class II
Status
Terminated
Recalling firm
Vectornate USA Inc
Quantity
130,000 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

Code information

Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076

Distribution pattern

US Nationwide distribution in the state of NJ.