FDA Device recall Z-1690-2017
8500M Handheld Pulse Oximeter
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of 8500M Handheld Pulse Oximeter by Nonin Medical, citing nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may no….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1690-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-29 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nonin Medical |
| Distribution | MI, NC, OH, VA |
Product
8500M Handheld Pulse Oximeter
Reason
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
Identifiers
| code_info | 502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079…502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1690-2017%22
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