Z-0262-2020Class II

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical...

Name: Z-0262-2020 POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical...
Creator: POM Medical LLC
Published: 2018-07-11
License: https://open.fda.gov/license/

POM Medical, LLC / initiated 2018-07-11 / Terminated / root cause: manufacturing process

FDA source

POM Medical LLC began a recall of POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations... on 2018-07-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0262-2020
Classification: Class II
Status: Terminated
Initiated: 2018-07-11
Posted: 2019-10-31
Terminated: 2021-01-04
Recalling firm: POM Medical, LLC
Product: 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.
Product code: BYG Mask, Oxygen
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated recall by telephone beginning 7/11/2018 requesting return of the product.
Quantity in commerce: 5,610 units
Distribution: Distribution was made to CA, FL, MO, OH, and PA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0262-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0262-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code BYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)