Nonin Medical, Inc 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Nonin Medical, Inc
Lot Codes / Batch Numbers
PRTNUM_72 PMDES1_01 LOTNUM_72 8825001 PKG ASSY, INT100 25605 8825001 PKG ASSY, INT100 414312 8825001 PKG ASSY, INT100 414353 8825001 PKG ASSY, INT100 414405 8825001 PKG ASSY, INT100 418061 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 36349 9705001 PKG ASSY, 8004CA, 20PK 36475 9705001 PKG ASSY, 8004CA, 20PK 36476 9705001 PKG ASSY, 8004CA, 20PK 36477 9705001 PKG ASSY, 8004CA, 20PK 36593 9705001 PKG ASSY, 8004CA, 20PK 36693 9705001 PKG ASSY, 8004CA, 20PK 36694 9705001 PKG ASSY, 8004CA, 20PK 36695 9705001 PKG ASSY, 8004CA, 20PK 36696 9705001 PKG ASSY, 8004CA, 20PK 36697 9705001 PKG ASSY, 8004CA, 20PK 36698 9705001 PKG ASSY, 8004CA, 20PK 36886 9705001 PKG ASSY, 8004CA, 20PK 36887 9705001 PKG ASSY, 8004CA, 20PK 36989 9705001 PKG ASSY, 8004CA, 20PK 37066 9705001 PKG ASSY, 8004CA, 20PK 37094 9705001 PKG ASSY, 8004CA, 20PK 37151 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 37374 9705001 PKG ASSY, 8004CA, 20PK 37410 9705001 PKG ASSY, 8004CA, 20PK 37514 9705001 PKG ASSY, 8004CA, 20PK 37515 9705001 PKG ASSY, 8004CA, 20PK 37591 9705001 PKG ASSY, 8004CA, 20PK 37607 9705001 PKG ASSY, 8004CA, 20PK 37669 9705001 PKG ASSY, 8004CA, 20PK 37670 9824001 PKG ASSY, 8003CA, 20 PK 36611 9824001 PKG ASSY, 8003CA, 20 PK 36888 9824001 PKG ASSY, 8003CA, 20 PK 36937 9824001 PKG ASSY, 8003CA, 20 PK 37090 9824001 PKG ASSY, 8003CA, 20 PK 37231 9824001 PKG ASSY, 8003CA, 20 PK 37575
Products Sold
PRTNUM_72 PMDES1_01 LOTNUM_72 8825001 PKG ASSY, INT100 25605 8825001 PKG ASSY, INT100 414312 8825001 PKG ASSY, INT100 414353 8825001 PKG ASSY, INT100 414405 8825001 PKG ASSY, INT100 418061 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 36349 9705001 PKG ASSY, 8004CA, 20PK 36475 9705001 PKG ASSY, 8004CA, 20PK 36476 9705001 PKG ASSY, 8004CA, 20PK 36477 9705001 PKG ASSY, 8004CA, 20PK 36593 9705001 PKG ASSY, 8004CA, 20PK 36693 9705001 PKG ASSY, 8004CA, 20PK 36694 9705001 PKG ASSY, 8004CA, 20PK 36695 9705001 PKG ASSY, 8004CA, 20PK 36696 9705001 PKG ASSY, 8004CA, 20PK 36697 9705001 PKG ASSY, 8004CA, 20PK 36698 9705001 PKG ASSY, 8004CA, 20PK 36886 9705001 PKG ASSY, 8004CA, 20PK 36887 9705001 PKG ASSY, 8004CA, 20PK 36989 9705001 PKG ASSY, 8004CA, 20PK 37066 9705001 PKG ASSY, 8004CA, 20PK 37094 9705001 PKG ASSY, 8004CA, 20PK 37151 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 37374 9705001 PKG ASSY, 8004CA, 20PK 37410 9705001 PKG ASSY, 8004CA, 20PK 37514 9705001 PKG ASSY, 8004CA, 20PK 37515 9705001 PKG ASSY, 8004CA, 20PK 37591 9705001 PKG ASSY, 8004CA, 20PK 37607 9705001 PKG ASSY, 8004CA, 20PK 37669 9705001 PKG ASSY, 8004CA, 20PK 37670 9824001 PKG ASSY, 8003CA, 20 PK 36611 9824001 PKG ASSY, 8003CA, 20 PK 36888 9824001 PKG ASSY, 8003CA, 20 PK 36937 9824001 PKG ASSY, 8003CA, 20 PK 37090 9824001 PKG ASSY, 8003CA, 20 PK 37231 9824001 PKG ASSY, 8003CA, 20 PK 37575
Nonin Medical, Inc is recalling SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (R due to Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during u. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 14, 2026