8500M Handheld Pulse Oximeter — Class II medical device recall Z-1690-2017
Terminated recall by Nonin Medical, Inc, reported 2017-04-05, distributed in MI, NC, OH, VA. Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500
| Recall number | Z-1690-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nonin Medical, Inc, Plymouth, MN, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2017-03-28 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-03-12 |
| Distributed | MI, NC, OH, VA |
| Countries outside the US | CA |
Product
8500M Handheld Pulse Oximeter
Reason for recall
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.
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-1690-2017. 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.