Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is… — Class II medical device recall Z-0213-2015
Terminated recall by Masimo Corporation, reported 2014-11-19, distributed nationwide. Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance w
| Recall number | Z-0213-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2014-09-30 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2016-03-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BR, CA, CH, CN, DK, ES, FR, GB, HK, IN, IT, JO, JP, KR, KW, MX, NL, PL, PT, TR |
| Lot numbers | 11AM7, 11CE2, 11EMM, 11FAU, 11FAV, 11FAW, 11GBY, 11HE6, 11HGF, 11HNO, 11J80, 11JCJ, 11JCK, 11K37, 11KQM, 11MA7, 11NDZ, 12B95, 12CP1, 12KP4, 12KP5, 12KQ7, 12KQ8, 12MAG, 12N17, 12N1S, 13AYG, 13C4K, 13C56, 13C57, 13C59, 13CNZ, 13DPZ, 13EPF, 13FPN, 19388V, 2062190-001, 3311, 3315, 3412 and 460 more |
| Serial numbers | 19388V, 2062190-001, 3315, 3449, 3577, 3578, 3636, E12JS1, R13FZJ, V13292, V13300, V13301, V13359, V14169, V14178, V14197, V14232, V14341, V14358, V14363, V14364, V14368, V14402, V14404, V14405 and 475 more |
| Model numbers | 11AM7, 11CE2, 11EMM, 11FAU, 11FAV, 11FAW, 11GBY, 11HE6, 11HGF, 11HNO, 11J80, 11JCJ, 11JCK, 11K37, 11KQM, 11MA7, 11NDZ, 12B95, 12CP1, 12KP4, 12KP5, 12KQ7, 12KQ8, 12MAG, 12N17 and 475 more |
Product
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Reason for recall
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
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-0213-2015. 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.