Class II — Nonin Medical, Inc
| Recalling firm | NONIN MEDICAL, INC. |
|---|---|
| Registered facility | NONIN MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | 8500M Handheld Pulse Oximeter |
| Quantity | 15 (11 US; 4 OUS) |
| Distribution | Distribution in US (MI, NC, OH, NC, VA), and CANADA |
| Initiated | 2016-09-29 |
| Classified | 2017-03-28 |
| Terminated | 2018-03-12 |
| Recall number | Z-1690-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nonin Medical, Inc (Z-1690-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75424/
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