rainbow Reusable Sensors — Class II medical device recall Z-0338-2016
Terminated recall by Masimo Corporation, reported 2015-12-02, distributed nationwide. These sensors were manufactured with incompatible configurations. This could result in sensors that will provi
| Recall number | Z-0338-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CR, DE, FR, KR, KW, NL, NO, TR |
| Model numbers | 2201, 2407, 2696, 2697 |
Product
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
Reason for recall
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
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-0338-2016. 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.