FDA Device recall Z-2267-2015
OxiMax N-65 Handheld Pulse Oximeter
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of OxiMax N-65 Handheld Pulse Oximeter by Covidien Formerly Nellcor Puritan Bennett, citing potential missing segments on the display that can result in misinterpretation of data.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2267-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-29 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | US |
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
Potential missing segments on the display that can result in misinterpretation of data.
Identifiers
| code_info | All Lots of Product Code N650, N65, N65-1, N65P, N65P-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2267-2015%22
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