POM Procedural Oxygen Masks — Class II medical device recall Z-0262-2020
Terminated recall by POM Medical LLC, reported 2019-11-06, distributed in CA, FL, MO, OH, PA. Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line
| Recall number | Z-0262-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | POM Medical LLC, Moorpark, CA, United States |
| Recall initiated | 2018-07-11 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-01-04 |
| Distributed | CA, FL, MO, OH, PA |
| Quantity | 5,610 units |
| Lot numbers | 021418-021421, 022218-022221, 032218-032221, 032618-032621, 032818-032821 |
| Model numbers | 1001-MF, 1001-MM, 301-0318LT, KE1001-MM |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0262-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.