Oxygen Mask — Class II medical device recall Z-2093-2014
Terminated recall by Salter Labs, reported 2014-07-30, distributed nationwide. The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
| Recall number | Z-2093-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Salter Labs, Carlsbad, CA, United States |
| Recall initiated | 2014-06-25 |
| Classified | 2014-07-22 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, GB, ID, MA, MX, NO, VE, ZA |
| Quantity | 584 units |
| Reason classes | labeling |
| Lot numbers | 021714, 022414, 042814, 051914, 052614, 090213, 090913 |
| Model numbers | 8120-7 |
Product
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Reason for recall
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
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-2093-2014. 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.