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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80296

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

Open FDA event record

Event summary

Timeline bucket
May 08, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Human Design Medical Llc

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

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Z-2530-2018
Recall number
Z-2530-2018
Initiated
May 08, 2018
Classification
Class III
Status
Terminated
Recalling firm
Human Design Medical Llc
Quantity
45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

Code information

Pending

Distribution pattern

US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.