Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77528

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
O-Two Medical Technologies, 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

O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

Z-2705-2017
Recall number
Z-2705-2017
Initiated
June 23, 2015
Classification
Class II
Status
Terminated
Quantity
4382 units (4082 units distributed USA)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.

Code information

Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016

Distribution pattern

Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland