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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65148

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, 2008
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SagaTech Electronics, 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

Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.

Z-1725-2013
Recall number
Z-1725-2013
Initiated
May 08, 2008
Classification
Class II
Status
Terminated
Quantity
152 units 77 devices from lot 13367 and 75 devices from lot 13710

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The outer jacket is receding away from the black sensor prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The outer jacket is receding away from the black sensor prematurely.

Code information

Model: 1.1 Lot numbers: 13367 and 13710

Distribution pattern

Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.