OxiMax N-65 Handheld Pulse Oximeter — Class II medical device recall Z-2267-2015
Terminated recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), reported 2015-08-05, distributed nationwide. Potential missing segments on the display that can result in misinterpretation of data.
| Recall number | Z-2267-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO, United States |
| Recall initiated | 2015-06-29 |
| Classified | 2015-07-27 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2017-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 211,426 units |
Product
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Reason for recall
Potential missing segments on the display that can result in misinterpretation of data.
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-2267-2015. 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.