Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83540

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

Open FDA event record

Event summary

Timeline bucket
July 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
POM 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

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

Z-0262-2020
Recall number
Z-0262-2020
Initiated
July 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
POM Medical LLC
Quantity
5,610 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.

Code information

Model 1001-MM - Lot numbers 021418-021421, 032218-032221, 032618-032621, and 032818-032821; Model KE1001-MM, an internal number used by one of the distributors (same as 1001-MM) - Lot numbers 021418-021421 and 032818-032821; Model 301-0318LT - Lot numbers 022218-022221, 032218-032221, 032618-032621; and Model 1001-MF - Lot number 032818-032821.

Distribution pattern

Distribution was made to CA, FL, MO, OH, and PA.