Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and… — Class II medical device recall Z-1187-2013
Terminated recall by Masimo Corporation, reported 2013-05-08, distributed nationwide. Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, w
| Recall number | Z-1187-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2013-03-13 |
| Classified | 2013-04-29 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 42,908 units |
| Model numbers | 2883, 9190, 9191, 9192, 9193, 9194, 9212, 9213, 9218, 9219, 9224, 9282, 9285 |
Product
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Reason for recall
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
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-1187-2013. 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.