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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78568

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

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Event summary

Timeline bucket
October 17, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Southmedic, 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

Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

Z-1288-2018
Recall number
Z-1288-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Southmedic, Inc.
Quantity
8,871 cases (25 masks per case) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

Code information

Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)

Distribution pattern

US Distribution to the state of California, and Internationally to Canada and Sweden