Medtronic Initiates Class I Recall of Pulse Oximetry Monitoring System in China

Jul 15, 2025 11:30 CST Updated 11:30

Medtronic

Medical Device Manufacturer

NMPA Releases Information on Medtronic Pulse Oximeter RecallRecall Level: Class I Recall. This recall is voluntarily initiated by Medtronic.The recall does not involve the discontinuation or return of the product.

Recalled Product

The recalled products areCovidien, a subsidiary of MedtronicProducedPulse Oximeter (Sp02 Patient Monitoring System）. Product Registration Certificate No. for Recall:China Medical Device Registration No. 20152072123。

Product Indications:This product can continuously and non-invasively measure the functional oxygen saturation of arterial hemoglobin and pulse rate in newborns, pediatric patients, and adults within medical institutions, and is to be used under the direct supervision of certified physicians or trained healthcare professionals.

Reason for Recall

Medtronic (Covidien) found through the review of complaint data that there may be instances where device alarms are not recognized during the use of pulse oximeters, potentially leading to patient harm.

To date, Covidien China has not received any complaints or adverse events related to patient injuries caused by this issue.

Number of Recalls This Time

Medtronic Solutions

Send a medical device voluntary recall notice letter to all affected customers, explaining the background and requirements of this recall, and return the signed confirmation letter;
Update the instructions.