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 Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported. |
| Product | SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box. |
| Quantity | 5892 (5452 US, 440 OUS) |
| Distribution | To be provided later. |
| Initiated | 2014-11-25 |
| Classified | 2014-12-31 |
| Terminated | 2015-09-01 |
| Recall number | Z-0901-2015 |
| 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-0901-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70045/
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