SenSmart — Class II medical device recall Z-0901-2015
Terminated recall by Nonin Medical, Inc, reported 2015-01-07. Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have r
| Recall number | Z-0901-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nonin Medical, Inc, Plymouth, MN, United States |
| Recall initiated | 2014-11-25 |
| Classified | 2014-12-31 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2015-09-01 |
| Model numbers | 3-WAVELENGTH, 4-WAVELENGTH, 8003CA, 9705-001, 9824-001 |
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.
Reason for recall
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.
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-0901-2015. 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.